## Protocol Section
### Identification Module
**NCT ID:** NCT02147379

**Brief Title:** Lurasidone and Cognition in Bipolar I Disorder

**Official Title:** Changes in Cognitive Functioning in Euthymic Bipolar Patients Treated With Lurasidone Versus Treatment as Usual; A Randomized, Open-Label Study.

#### Organization Study ID Info
**ID:** H14-00290
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2017-01-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-02

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-02-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-10

**Type:** ACTUAL

#### Start Date
**Date:** 2014-05

**Status Verified Date:** 2017-02

#### Study First Post Date
**Date:** 2014-05-26
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-08
**Study First Submit QC Date:** 2014-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of British Columbia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I disorder (manic depression), who are in remission from an episode. Participants who show cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on to their current medication(s) or continue their usual treatment for 6 weeks. Participants will have 3 clinical visits and 2 telephone appointments during the study. Given the preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.

### Conditions Module

**Conditions:**

- Bipolar I Disorder

**Keywords:**

- Bipolar Disorder

- Cognition

- Euthymic

- Lurasidone

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 53

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.

**Intervention Names:**

- Drug: Lurasidone

**Label:** Lurasidone

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients randomized to this arm will continue their usual treatment.

**Label:** Treatment as usual

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lurasidone

**Name:** Lurasidone

**Other Names:**

- Latuda

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The International Society for Bipolar Disorders-Battery for Assessment of Neurocognition (ISBD-BANC) will be administered to assess cognitive functioning at baseline and at endpoint ( change in scores on cognitive tests) to evaluate the efficacy of lurasidone on cognitive changes in bipolar disorder.

**Measure:** Cognitive Change in Bipolar I disorder after treatment with Lurasidone

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. All patients must be taking either lithium or valproate or one of the atypical antipsychotics for mood stabilization.
2. Patients who show cognitive impairments (-0.25 standard deviations (SD) or below) on either the Trail Making Test- trial B (TMT-B) or California Verbal Learning Test (CVLT) trials 1 to 5, or CVLT long delay free recall, at baseline visit.
3. Males or females aged 19 to 65 years inclusive.
4. Diagnostic and Statistical Manual IV edition (DSM-IV TR) diagnosis of Bipolar Type I Disorder, with or without a history of psychosis.
5. Clinically stable with a Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to 8.
6. A sufficient level of English using a language screening questionnaire.
7. Capability of understanding, consenting to, and complying with the requirements of the study.

Exclusion Criteria:

1. A history of unstable or inadequately treated medical illnesses, including moderate to severe brain injury, or neurological illnesses impacting cognitive function.
2. Treatment with Electroconvulsive Therapy (ECT) within eight weeks prior to enrolment; or treatment with an experimental drug within 30 days prior to enrolment.
3. Axis I diagnosis of substance abuse or dependence within the past month.
4. Significant risk of harm to self or others, in the opinion of the investigator.
5. Pregnancy or lactation in female subjects.
6. Liver function tests (AST and ALT) three times the upper limit of normal. -

**Maximum Age:** 65 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Vancouver

**Country:** Canada

**Facility:** University of British Columbia, Department of Psychiatry

**State:** British Columbia

**Zip:** V6T 2A1

#### Overall Officials

**Official 1:**

**Affiliation:** University of British Columbia

**Name:** Lakshmi N Yatham, MBBS,FRCPC,MRCPsych (UK),MB

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Yatham LN, Mackala S, Basivireddy J, Ahn S, Walji N, Hu C, Lam RW, Torres IJ. Lurasidone versus treatment as usual for cognitive impairment in euthymic patients with bipolar I disorder: a randomised, open-label, pilot study. Lancet Psychiatry. 2017 Mar;4(3):208-217. doi: 10.1016/S2215-0366(17)30046-9. Epub 2017 Feb 7. Erratum In: Lancet Psychiatry. 2017 Mar;4(3):185.

**PMID:** 28185899

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4996

- Name: Bipolar Disorder

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000058669

- Term: Adrenergic alpha-2 Receptor Antagonists

- ID: D000000317

- Term: Adrenergic alpha-Antagonists

- ID: D000018674

- Term: Adrenergic Antagonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000058830

- Term: Serotonin 5-HT2 Receptor Antagonists

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000065127

- Term: Dopamine D2 Receptor Antagonists

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M348

- Name: Lurasidone Hydrochloride

- Relevance: HIGH

- As Found: Thrombolysis

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29195

- Name: Adrenergic alpha-2 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M3669

- Name: Adrenergic alpha-Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20755

- Name: Adrenergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069056

- Term: Lurasidone Hydrochloride

### Misc Info Module

- Version Holder: 2024-05-24
