## Protocol Section
### Identification Module
**NCT ID:** NCT00986479

**Brief Title:** This is a Study to Determine the Antidepressant Effects of AZD6765

**Official Title:** An Investigation of the Antidepressant Effects of an NMDA Antagonist in Treatment-Resistant Major Depression

**NCT ID Aliases:**
- NCT00995111
#### Organization Study ID Info
**ID:** D6702C00015
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-10-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-10-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-10-21

**Type:** ESTIMATED

**Results First Submit Date:** 2014-10-15

**Results First Submit QC Date:** 2014-10-15

#### Start Date
**Date:** 2009-12

**Status Verified Date:** 2014-10

#### Study First Post Date
**Date:** 2009-09-30
**Type:** ESTIMATED
**Study First Submit Date:** 2009-09-24
**Study First Submit QC Date:** 2009-09-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.

### Conditions Module

**Conditions:**

- Treatment Resistant Major Depressive Disorder

**Keywords:**

- Patients

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.

**Intervention Names:**

- Drug: AZD6765

**Label:** AZD6765 (150 mg) / Placebo

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.

**Intervention Names:**

- Drug: Placebo to AZD6765

**Label:** Placebo / AZD6765 (150 mg)

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AZD6765 (150 mg) / Placebo

**Description:** Single IV infusion of 150 mg AZD6765.

**Name:** AZD6765

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo / AZD6765 (150 mg)

**Description:** Single IV infusion of Placebo to AZD6765

**Name:** Placebo to AZD6765

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.

**Measure:** Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

#### Secondary Outcomes

**Description:** Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score \<10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.

**Measure:** The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** Response defined as a \>= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.

**Measure:** The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.

**Measure:** Scale for Suicide Ideation (SSI) Total Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.

**Measure:** Hamilton Anxiety Rating Scale (HAM-A) Total Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.

**Measure:** Hamilton Depression Rating Scale-17 Item (HDRS) Total Score

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing

**Description:** The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point.

**Measure:** Visual Analogue Scale (VAS) Depressed Score

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing

**Description:** Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.

**Measure:** Clinician-Administered Dissociative States Scale (CADSS) Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing

**Description:** The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126.

18 is considered to be the best outcome, 126 the worst.

**Measure:** Brief Psychiatric Rating Scale (BPRS) Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.

**Measure:** Beck Depression Inventory (BDI) Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.

**Measure:** Young Mania Rating Scale (YMRS) Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point.

**Measure:** Visual Analogue Scale (VAS) Anxious Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

**Description:** Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.

**Measure:** Brief Psychiatric Rating Scale (BPRS) Positive Score.

**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features
* Females must be of non-childbearing potential.

Exclusion Criteria:

* Treatment with Clozapine or ECT within 3 months prior to study
* Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bethesda

**Country:** United States

**Facility:** Research Site

**State:** Maryland

#### Overall Officials

**Official 1:**

**Affiliation:** National Institute of Mental Health (NIMH)

**Name:** Carlos A Zarate, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

**PMID:** 34510411

**Citation:** Lepow L, Luckenbaugh DA, Park L, Henter ID, Zarate CA Jr. Case series: Antidepressant effects of low-affinity and low-trapping NMDA receptor antagonists did not predict response to ketamine in seven subjects. J Psychiatr Res. 2017 Mar;86:55-57. doi: 10.1016/j.jpsychires.2016.10.023. Epub 2016 Nov 22. No abstract available.

**PMID:** 27914292

**Citation:** Zarate CA Jr, Mathews D, Ibrahim L, Chaves JF, Marquardt C, Ukoh I, Jolkovsky L, Brutsche NE, Smith MA, Luckenbaugh DA. A randomized trial of a low-trapping nonselective N-methyl-D-aspartate channel blocker in major depression. Biol Psychiatry. 2013 Aug 15;74(4):257-64. doi: 10.1016/j.biopsych.2012.10.019. Epub 2012 Dec 1.

**PMID:** 23206319

#### See Also Links

**Label:** D6702C00015 Clinical Study Report Synopsis

**URL:** http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=213&filename=D6702C00015_Clinical_Study_Report_Synopsis.pdf

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7060

- Name: Depressive Disorder, Major

- Relevance: HIGH

- As Found: Major Depressive Disorder

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

- ID: D000003865

- Term: Depressive Disorder, Major

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PsychDr

- Name: Psychotropic Drugs

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** AZD6765 (150 mg)

**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.

**ID:** EG000

**Other Num Affected:** 21

**Other Num at Risk:** 22

**Serious Number At Risk:** 22

**Title:** AZD6765 (150 mg)

**Group ID:** EG001

**Title:** Placebo

**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.

**ID:** EG001

**Other Num Affected:** 20

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** 

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** 

**Term:** Tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Hypoacusis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Tinnitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Vision blurred

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Eye irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Decreased apetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Increased apetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Thirst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Abdominal discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Faeces discoloured

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Weight increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Libido increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Felt faint

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Dental care

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** 

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Gingival disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Salivary hypersecretion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Mouth ulceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Glossodynia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Muscle rigidity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Tic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Malignant dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Nasal congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Disturbance in attention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Initial insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Terminal insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Hallucination

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Sleep disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Memory impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Hypokinesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Psychomotor activity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Dysarthria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Suicidal behaviour

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Suicidal ideation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Skin irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Surgery

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** 

**Term:** Hearing impaired

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Body temperature decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Dissociation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Euphoric mood

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Social avoindant behaviour

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Abnormal behaviour

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Feeling abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Body temperature increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Energy increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Hypoaesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Fear of falling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Paraesthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Visual impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Abnormal dreams

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** False Sensation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 12

**Group ID:** BG001

**Value:** 10

**Group ID:** BG002

**Value:** 22

**Units:** Participants

### Group

**ID:** BG000

**Title:** AZD6765 (150 mg)/ Placebo

**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.

### Group

**ID:** BG001

**Title:** Placebo/AZD6765 (150 mg)

**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.9

**Value:** 50.7

#### Measurement

**Group ID:** BG001

**Spread:** 10.5

**Value:** 52.4

#### Measurement

**Group ID:** BG002

**Spread:** 10.1

**Value:** 51.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** ClinicalTrialTransparency@astrazeneca.com
**Organization:** AstraZeneca
**Title:** Clinical Trial Transparency
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.262
- **Upper Limit:** 
- **Value:** 26.881
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 28.618
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.262
- **Upper Limit:** 
- **Value:** 25.381
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 29.718
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.262
- **Upper Limit:** 
- **Value:** 25.835
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 29.818
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.262
- **Upper Limit:** 
- **Value:** 26.517
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 29.418
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.262
- **Upper Limit:** 
- **Value:** 27.654
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 29.118
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.288
- **Upper Limit:** 
- **Value:** 29.161
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 31.368
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.288
- **Upper Limit:** 
- **Value:** 30.732
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 30.368
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.288
- **Upper Limit:** 
- **Value:** 31.447
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.342
- **Upper Limit:** 
- **Value:** 31.222
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.326
- **Upper Limit:** 
- **Value:** 0.955
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.330
- **Upper Limit:** 
- **Value:** 0.939
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.326
- **Upper Limit:** 
- **Value:** 1.137
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.330
- **Upper Limit:** 
- **Value:** 1.039
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.326
- **Upper Limit:** 
- **Value:** 1.137
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.330
- **Upper Limit:** 
- **Value:** 0.989
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.326
- **Upper Limit:** 
- **Value:** 0.864
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.330
- **Upper Limit:** 
- **Value:** 0.939
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.326
- **Upper Limit:** 
- **Value:** 1.364
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.330
- **Upper Limit:** 
- **Value:** 1.539
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.328
- **Upper Limit:** 
- **Value:** 1.236
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.330
- **Upper Limit:** 
- **Value:** 1.189
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.328
- **Upper Limit:** 
- **Value:** 1.379
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.332
- **Upper Limit:** 
- **Value:** 1.226
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.328
- **Upper Limit:** 
- **Value:** 1.379
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.332
- **Upper Limit:** 
- **Value:** 1.507
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.181
- **Upper Limit:** 
- **Value:** 16.211
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.207
- **Upper Limit:** 
- **Value:** 17.160
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.181
- **Upper Limit:** 
- **Value:** 16.666
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.198
- **Upper Limit:** 
- **Value:** 17.675
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.190
- **Upper Limit:** 
- **Value:** 16.817
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.198
- **Upper Limit:** 
- **Value:** 18.125
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.190
- **Upper Limit:** 
- **Value:** 17.055
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.198
- **Upper Limit:** 
- **Value:** 18.525
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.190
- **Upper Limit:** 
- **Value:** 18.817
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.207
- **Upper Limit:** 
- **Value:** 19.631
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.977
- **Upper Limit:** 
- **Value:** 15.930
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.008
- **Upper Limit:** 
- **Value:** 17.389
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.977
- **Upper Limit:** 
- **Value:** 14.975
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.008
- **Upper Limit:** 
- **Value:** 17.739
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.977
- **Upper Limit:** 
- **Value:** 15.475
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.008
- **Upper Limit:** 
- **Value:** 18.039
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.977
- **Upper Limit:** 
- **Value:** 16.112
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.008
- **Upper Limit:** 
- **Value:** 17.339
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.977
- **Upper Limit:** 
- **Value:** 16.748
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.008
- **Upper Limit:** 
- **Value:** 17.639
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.977
- **Upper Limit:** 
- **Value:** 16.732
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.008
- **Upper Limit:** 
- **Value:** 19.289
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.977
- **Upper Limit:** 
- **Value:** 17.732
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.008
- **Upper Limit:** 
- **Value:** 19.039
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.991
- **Upper Limit:** 
- **Value:** 18.160
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.024
- **Upper Limit:** 
- **Value:** 19.438
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.137
- **Upper Limit:** 
- **Value:** 55.614
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.197
- **Upper Limit:** 
- **Value:** 60.562
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.137
- **Upper Limit:** 
- **Value:** 58.614
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.197
- **Upper Limit:** 
- **Value:** 57.662
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.137
- **Upper Limit:** 
- **Value:** 60.750
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.197
- **Upper Limit:** 
- **Value:** 59.062
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.137
- **Upper Limit:** 
- **Value:** 55.614
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.197
- **Upper Limit:** 
- **Value:** 61.212
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.137
- **Upper Limit:** 
- **Value:** 62.160
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.197
- **Upper Limit:** 
- **Value:** 64.762
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.166
- **Upper Limit:** 
- **Value:** 65.753
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.197
- **Upper Limit:** 
- **Value:** 63.262
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.166
- **Upper Limit:** 
- **Value:** 66.896
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.197
- **Upper Limit:** 
- **Value:** 63.312
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.166
- **Upper Limit:** 
- **Value:** 68.467
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.264
- **Upper Limit:** 
- **Value:** 65.576
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.900
- **Upper Limit:** 
- **Value:** 4.104
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** 1.997
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.909
- **Upper Limit:** 
- **Value:** 3.324
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** 2.297
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.900
- **Upper Limit:** 
- **Value:** 2.831
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** 2.047
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.900
- **Upper Limit:** 
- **Value:** 1.240
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** 1.497
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.900
- **Upper Limit:** 
- **Value:** 1.013
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** 1.147
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.910
- **Upper Limit:** 
- **Value:** 1.360
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** 1.397
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.910
- **Upper Limit:** 
- **Value:** 1.456
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.921
- **Upper Limit:** 
- **Value:** 1.447
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.910
- **Upper Limit:** 
- **Value:** 1.313
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.932
- **Upper Limit:** 
- **Value:** 1.212
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.271
- **Upper Limit:** 
- **Value:** 32.191
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 32.896
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.271
- **Upper Limit:** 
- **Value:** 30.237
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 33.496
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.271
- **Upper Limit:** 
- **Value:** 30.555
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 33.696
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.271
- **Upper Limit:** 
- **Value:** 30.737
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 31.772
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.271
- **Upper Limit:** 
- **Value:** 33.418
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 33.596
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.291
- **Upper Limit:** 
- **Value:** 32.882
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 34.496
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.291
- **Upper Limit:** 
- **Value:** 34.168
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.314
- **Upper Limit:** 
- **Value:** 33.046
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.291
- **Upper Limit:** 
- **Value:** 35.739
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.335
- **Upper Limit:** 
- **Value:** 34.428
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.524
- **Upper Limit:** 
- **Value:** 21.081
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.538
- **Upper Limit:** 
- **Value:** 22.886
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.524
- **Upper Limit:** 
- **Value:** 22.217
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.546
- **Upper Limit:** 
- **Value:** 23.122
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.524
- **Upper Limit:** 
- **Value:** 21.535
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.538
- **Upper Limit:** 
- **Value:** 23.586
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.524
- **Upper Limit:** 
- **Value:** 21.126
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.538
- **Upper Limit:** 
- **Value:** 23.686
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.524
- **Upper Limit:** 
- **Value:** 22.444
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.538
- **Upper Limit:** 
- **Value:** 22.936
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.531
- **Upper Limit:** 
- **Value:** 22.923
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.538
- **Upper Limit:** 
- **Value:** 24.586
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.531
- **Upper Limit:** 
- **Value:** 23.494
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.538
- **Upper Limit:** 
- **Value:** 23.786
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.531
- **Upper Limit:** 
- **Value:** 24.447
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.546
- **Upper Limit:** 
- **Value:** 24.070
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.412
- **Upper Limit:** 
- **Value:** 4.294
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.427
- **Upper Limit:** 
- **Value:** 3.626
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.412
- **Upper Limit:** 
- **Value:** 3.748
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.427
- **Upper Limit:** 
- **Value:** 3.526
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.412
- **Upper Limit:** 
- **Value:** 3.475
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.427
- **Upper Limit:** 
- **Value:** 3.526
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.412
- **Upper Limit:** 
- **Value:** 3.748
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.427
- **Upper Limit:** 
- **Value:** 3.526
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.412
- **Upper Limit:** 
- **Value:** 3.748
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.427
- **Upper Limit:** 
- **Value:** 3.326
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.419
- **Upper Limit:** 
- **Value:** 3.699
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.427
- **Upper Limit:** 
- **Value:** 3.676
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.419
- **Upper Limit:** 
- **Value:** 4.270
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.427
- **Upper Limit:** 
- **Value:** 3.476
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.419
- **Upper Limit:** 
- **Value:** 4.366
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.435
- **Upper Limit:** 
- **Value:** 4.339
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.415
- **Upper Limit:** 
- **Value:** 43.898
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.479
- **Upper Limit:** 
- **Value:** 41.929
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.415
- **Upper Limit:** 
- **Value:** 44.216
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.479
- **Upper Limit:** 
- **Value:** 44.079
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.415
- **Upper Limit:** 
- **Value:** 42.853
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.479
- **Upper Limit:** 
- **Value:** 44.729
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.415
- **Upper Limit:** 
- **Value:** 44.580
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.479
- **Upper Limit:** 
- **Value:** 46.029
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.415
- **Upper Limit:** 
- **Value:** 44.989
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.479
- **Upper Limit:** 
- **Value:** 47.229
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.447
- **Upper Limit:** 
- **Value:** 44.718
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.479
- **Upper Limit:** 
- **Value:** 50.479
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.447
- **Upper Limit:** 
- **Value:** 42.623
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.479
- **Upper Limit:** 
- **Value:** 48.279
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.447
- **Upper Limit:** 
- **Value:** 50.147
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.551
- **Upper Limit:** 
- **Value:** 56.595
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.264
- **Upper Limit:** 
- **Value:** 9.433
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.274
- **Upper Limit:** 
- **Value:** 8.946
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.264
- **Upper Limit:** 
- **Value:** 8.751
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.274
- **Upper Limit:** 
- **Value:** 8.996
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.264
- **Upper Limit:** 
- **Value:** 8.660
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.274
- **Upper Limit:** 
- **Value:** 8.996
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.264
- **Upper Limit:** 
- **Value:** 8.751
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.279
- **Upper Limit:** 
- **Value:** 8.666
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.264
- **Upper Limit:** 
- **Value:** 9.114
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.274
- **Upper Limit:** 
- **Value:** 9.296
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.269
- **Upper Limit:** 
- **Value:** 9.118
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.274
- **Upper Limit:** 
- **Value:** 9.296
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.269
- **Upper Limit:** 
- **Value:** 9.118
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.274
- **Upper Limit:** 
- **Value:** 9.446
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.269
- **Upper Limit:** 
- **Value:** 9.356
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.279
- **Upper Limit:** 
- **Value:** 9.338
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
**Type:** PRIMARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score \<10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
**Parameter Type:** NUMBER
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** Response defined as a \>= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.
**Parameter Type:** NUMBER
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Scale for Suicide Ideation (SSI) Total Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Hamilton Anxiety Rating Scale (HAM-A) Total Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing
**Title:** Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing
**Title:** Visual Analogue Scale (VAS) Depressed Score
**Type:** SECONDARY
**Unit of Measure:** Scores on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing
**Title:** Clinician-Administered Dissociative States Scale (CADSS) Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126.

18 is considered to be the best outcome, 126 the worst.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Brief Psychiatric Rating Scale (BPRS) Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Description:** Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Beck Depression Inventory (BDI) Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Description:** Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Young Mania Rating Scale (YMRS) Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 12
**Description:** The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between "extreme sad" (0-mm) and "extreme happy" (100-mm), with a median "normal" point.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT population including all randomized patients who were given study treatment.
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Visual Analogue Scale (VAS) Anxious Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 13
**Description:** Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Reporting Status:** POSTED
**Time Frame:** 60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.
**Title:** Brief Psychiatric Rating Scale (BPRS) Positive Score.
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** OG000
**Title:** AZD6765 (150 mg)
##### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
**ID:** FG000
**Title:** AZD6765 (150 mg)
#### Group
**Description:** Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Period 1
##### Withdraw
**Type:** Improved mood
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Administrative reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
#### Period
**Title:** Period 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Screening for eligibility and washout of restricted medications.
**Recruitment Details:** A total of 27 patients were enrolled. Of these, 22 patients were randomized to either: (1) AZD6765 (150 mg) followed by placebo or (2) placebo followed by AZD6765 (150 mg) in a crossover study design. A total of 20 patients completed both treatment periods of the study.
**Has Results:** True