## Protocol Section
### Identification Module
**NCT ID:** NCT02684279

**Brief Title:** Dasotraline Binge Eating Disorder Extension Study

**Official Title:** An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults With Binge-eating Disorder

#### Organization Study ID Info
**ID:** SEP360-322
#### Organization
**Class:** INDUSTRY
**Full Name:** Sumitomo Pharma America, Inc.
### Status Module
#### Completion Date
**Date:** 2019-06-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-08-12

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-06-24

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-08-12

**Type:** ACTUAL

**Results First Submit Date:** 2020-06-17

**Results First Submit QC Date:** 2020-07-28

#### Start Date
**Date:** 2016-02-29

**Type:** ACTUAL

**Status Verified Date:** 2020-07

#### Study First Post Date
**Date:** 2016-02-17
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-28
**Study First Submit QC Date:** 2016-02-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sumitomo Pharma America, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Binge Eating Disorder Extension Study.

**Detailed Description:** This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.

### Conditions Module

**Conditions:**

- Binge Eating Disorder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Masking Description:** open-label

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 533

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 4, 6, 8 mg flexibly dosed

**Intervention Names:**

- Drug: Dasotraline

**Label:** Dasotraline

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dasotraline

**Description:** Dasotraline 4, 6, 8 mg flexibly dosed once daily

**Name:** Dasotraline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior

**Measure:** Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)

**Time Frame:** Baseline to Week 52

**Description:** Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior

**Measure:** Frequency and Severity of Suicidal Behavior Using the C-SSRS

**Time Frame:** Baseline to Week 52

#### Secondary Outcomes

**Description:** Change in body weight

**Measure:** Change in Body Weight

**Time Frame:** Baseline, Week 52

**Description:** Percent change in body weight (kg)

**Measure:** Percent Change in Body Weight (kg)

**Time Frame:** Baseline, Week 52

**Description:** Change in Body Mass Index

**Measure:** Change in Body Mass Index

**Time Frame:** Baseline, Week 52

**Description:** Percent change in Body Mass Index (kg/m\^2)

**Measure:** Percent Change in Body Mass Index (kg/m^2)

**Time Frame:** Baseline, Week 52

**Description:** Change in fasting lipid panel, Triglyceride's

**Measure:** Change in Fasting Lipid Panel, Triglyceride's

**Time Frame:** Baseline, Week 52

**Description:** Change in fasting lipid panel , total cholesterol

**Measure:** Change in Fasting Lipid Panel , Total Cholesterol

**Time Frame:** Baseline, Week 52

**Description:** Change in fasting lipid panel, high-density lipoprotein \[HDL\] cholesterol,

**Measure:** Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,

**Time Frame:** Baseline, Week 52

**Description:** Change in fasting lipid panel, low-density lipoprotein \[LDL\] cholesterol)

**Measure:** Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)

**Time Frame:** Baseline, Week 52

**Description:** Change in hemoglobin A1c levels

**Measure:** Change in Hemoglobin A1c Levels

**Time Frame:** Baseline, Week 52

**Description:** Change in fasting glucose levels

**Measure:** Change in Fasting Glucose Levels

**Time Frame:** Baseline, Week 52

**Description:** Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.

**Measure:** Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores

**Time Frame:** Baseline, Week 52

**Description:** Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.

Item 4: Over the past 28 days, how many times have you eaten what other people would regard as an unusually large amount of food (given the circumstances)?

Item 5: On how many of these times did you have a sense of having lost control over your eating (at the time that you were eating)?

**Measure:** Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores

**Time Frame:** Baseline, Week 52

**Description:** Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.

Item 6: Over the past 28 days, on how many DAYS have such episodes of overeating occurred (i.e., you have eaten an unusually large amount of food and have had a sense of loss of control at the time)?

**Measure:** Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores

**Time Frame:** Baseline, Week 52

**Description:** Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.

**Measure:** Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score

**Time Frame:** Baseline, Week 52

**Description:** The Sheehan Disability Scale (SDS) 3 subscales (work/school, social life, home life) are rated on the following scale: 0 = not at all; 1-3 = mildly; 4-6 = moderately; 7-9 =markedly; 10 = extremely. The 3 items can be combined into a single global measure of impairment (SDS total score) that ranges from 0 (unimpaired) to 30 (highly impaired). A higher subscale score and total score are associated with greater illness severity.

**Measure:** Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability)

**Time Frame:** Baseline, Week 52

**Description:** Hamilton Anxiety Rating Scale (HAM-A) total score HAM-A total score ranges from 0 to 56. A higher score is associated with a greater degree of anxiety.

**Measure:** Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

**Time Frame:** Baseline, Week 52

**Description:** Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms

**Measure:** Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

**Time Frame:** Baseline, Week 52

**Description:** Change in SF-12 two component scores (physical, mental health) for Subjects Continued from Study SEP360-221 The SF-12 is a 12-item self-report questionnaire. Physical Component Summary (PCS) and Mental Component Summary (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

**Measure:** Change in SF-12 Two Component Scores (Physical, Mental Health)

**Time Frame:** Baseline, Week 52

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Completion of the treatment period of a dasotraline core study (ie, SEP360 221 or SEP360-321) for the treatment of BED.
* Subject has agreed to participate by providing written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator.
* Subject has not taken any medication other than the study drug for the purpose of controlling BED symptoms during the core study.
* Female subject must have a negative urine pregnancy test at open label (OL) Baseline; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
* Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control (see Section 22, Appendix III) throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
* Subject is judged by the investigator to be suitable for participation in a 12 month clinical trial involving open-label dasotraline treatment.
* Subject can read well enough to understand the informed consent form and other subject materials.

Exclusion Criteria:

* Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
* Subject is considered a suicide risk in the investigator's opinion or has any previous history of suicide attempt within the past 12 months.
* Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at OL Baseline. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
* Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
* Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
* Subject is breastfeeding.
* Subject is at high risk of non-compliance in the investigator's opinion.

**Maximum Age:** 56 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** Noesis Parma

**State:** Arizona

**Zip:** 85032

**Location 2:**

**City:** Beverly Hills

**Country:** United States

**Facility:** Southern California Research

**State:** California

**Zip:** 90210

**Location 3:**

**City:** Encino

**Country:** United States

**Facility:** Pharmacology Research Institute

**State:** California

**Zip:** 91316

**Location 4:**

**City:** Garden Grove

**Country:** United States

**Facility:** Collaborative NeuroScience Network Inc.

**State:** California

**Zip:** 92845

**Location 5:**

**City:** Newport Beach

**Country:** United States

**Facility:** Pharmacology Research Institute

**State:** California

**Zip:** 92660

**Location 6:**

**City:** San Marcos

**Country:** United States

**Facility:** Artemis Institute for Clinical Research

**State:** California

**Zip:** 92078

**Location 7:**

**City:** Santa Ana

**Country:** United States

**Facility:** Syrentis Clinical Research

**State:** California

**Zip:** 92705

**Location 8:**

**City:** Colorado Springs

**Country:** United States

**Facility:** MCB Clinical Research Centers, LLC

**State:** Colorado

**Zip:** 80910

**Location 9:**

**City:** Denver

**Country:** United States

**Facility:** Weiss and Lytle, PLLC

**State:** Colorado

**Zip:** 80209*

**Location 10:**

**City:** Cromwell

**Country:** United States

**Facility:** CT Clinical Research

**State:** Connecticut

**Zip:** 06416

**Location 11:**

**City:** Fort Myers

**Country:** United States

**Facility:** Gulfcoast Clinical Research Center

**State:** Florida

**Zip:** 33912

**Location 12:**

**City:** Jacksonville

**Country:** United States

**Facility:** Clinical Neuroscience Solutions, Inc.

**State:** Florida

**Zip:** 32256

**Location 13:**

**City:** North Miami

**Country:** United States

**Facility:** Segal Institute for Clinical Research

**State:** Florida

**Zip:** 33161

**Location 14:**

**City:** Orlando

**Country:** United States

**Facility:** Clinical Neuroscience Solutions, Inc.

**State:** Florida

**Zip:** 32801

**Location 15:**

**City:** South Miami

**Country:** United States

**Facility:** Miami Research Associates

**State:** Florida

**Zip:** 33143

**Location 16:**

**City:** Alpharetta

**Country:** United States

**Facility:** Institute of Advanced Medical Research

**State:** Georgia

**Zip:** 30005

**Location 17:**

**City:** Atlanta

**Country:** United States

**Facility:** Neuotrials Research, Inc.

**State:** Georgia

**Zip:** 30342

**Location 18:**

**City:** Marietta

**Country:** United States

**Facility:** Northwest Behavioral Research Center

**State:** Georgia

**Zip:** 30060

**Location 19:**

**City:** Libertyville

**Country:** United States

**Facility:** Capstone Clinical Research

**State:** Illinois

**Zip:** 60048

**Location 20:**

**City:** Indianapolis

**Country:** United States

**Facility:** Goldpoint Clinical Research, Inc.

**State:** Indiana

**Zip:** 46260

**Location 21:**

**City:** Prairie Village

**Country:** United States

**Facility:** Phoenix Medical Research, Inc. Suite 135

**State:** Kansas

**Zip:** 66208

**Location 22:**

**City:** Wichita

**Country:** United States

**Facility:** Cyress Medical Research Center, LLC

**State:** Kansas

**Zip:** 67226

**Location 23:**

**City:** Belmont

**Country:** United States

**Facility:** McLean Hospital

**State:** Massachusetts

**Zip:** 02478

**Location 24:**

**City:** Boston

**Country:** United States

**Facility:** Boston Clinical Trials

**State:** Massachusetts

**Zip:** 02131

**Location 25:**

**City:** Methuen

**Country:** United States

**Facility:** ActivMed Practices & Research, Inc.

**State:** Massachusetts

**Zip:** 01844

**Location 26:**

**City:** Watertown

**Country:** United States

**Facility:** Adams Clinical Trials, LLC

**State:** Massachusetts

**Zip:** 02472

**Location 27:**

**City:** Saint Charles

**Country:** United States

**Facility:** St. Charles Psychiatric Associates - Midwest Research Group

**State:** Missouri

**Zip:** 63304

**Location 28:**

**City:** Portsmouth

**Country:** United States

**Facility:** ActivMed Practices and Research, Inc.

**State:** New Hampshire

**Zip:** 03801

**Location 29:**

**City:** Cherry Hill

**Country:** United States

**Facility:** Center for Emotional Fitness

**State:** New Jersey

**Zip:** 08002

**Location 30:**

**City:** Princeton

**Country:** United States

**Facility:** Princeton Medical Institute, LCC

**State:** New Jersey

**Zip:** 08540

**Location 31:**

**City:** Mount Kisco

**Country:** United States

**Facility:** Bioscience Research, LLC

**State:** New York

**Zip:** 10549

**Location 32:**

**City:** New York

**Country:** United States

**Facility:** Manhattan Behavioral Medicine, PLLC

**State:** New York

**Zip:** 10036

**Location 33:**

**City:** New York

**Country:** United States

**Facility:** The Medical Research Network, LLC

**State:** New York

**Zip:** 10128

**Location 34:**

**City:** Raleigh

**Country:** United States

**Facility:** Wake Research Associates

**State:** North Carolina

**Zip:** 27612

**Location 35:**

**City:** Akron

**Country:** United States

**Facility:** Radiant Research, Inc.

**State:** Ohio

**Zip:** 44311

**Location 36:**

**City:** Cincinnati

**Country:** United States

**Facility:** Patient Priority Clinical Sites

**State:** Ohio

**Zip:** 45215

**Location 37:**

**City:** Dayton

**Country:** United States

**Facility:** Midwest Clinical Research Center

**State:** Ohio

**Zip:** 45417

**Location 38:**

**City:** Mason

**Country:** United States

**Facility:** Lindner Center Of Hope

**State:** Ohio

**Zip:** 45040

**Location 39:**

**City:** Oklahoma City

**Country:** United States

**Facility:** IPS Research Company

**State:** Oklahoma

**Zip:** 73103

**Location 40:**

**City:** Medford

**Country:** United States

**Facility:** Sunstone Medical Research, LLC

**State:** Oregon

**Zip:** 97504

**Location 41:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Center for Clinical Investigatons, INC.

**State:** Oregon

**Zip:** 97214

**Location 42:**

**City:** Salem

**Country:** United States

**Facility:** Oregon Center for Clinical Investigations, Inc.

**State:** Oregon

**Zip:** 97301

**Location 43:**

**City:** Allentown

**Country:** United States

**Facility:** Lehigh Center For Clinical Research

**State:** Pennsylvania

**Zip:** 18104

**Location 44:**

**City:** Anderson

**Country:** United States

**Facility:** Radiant Research, Inc.

**State:** South Carolina

**Zip:** 29621

**Location 45:**

**City:** Greer

**Country:** United States

**Facility:** Radient Research, Inc.

**State:** South Carolina

**Zip:** 29650

**Location 46:**

**City:** Mount Pleasant

**Country:** United States

**Facility:** Coastal Carolina Research Center

**State:** South Carolina

**Zip:** 29464

**Location 47:**

**City:** Memphis

**Country:** United States

**Facility:** Clinical Neuroscience Solutons, Inc.

**State:** Tennessee

**Zip:** 38119

**Location 48:**

**City:** Nashville

**Country:** United States

**Facility:** Clinical Research Associates, Inc.

**State:** Tennessee

**Zip:** 37203

**Location 49:**

**City:** Austin

**Country:** United States

**Facility:** Donald J. Garcia Jr., MD

**State:** Texas

**Zip:** 78737

**Location 50:**

**City:** Houston

**Country:** United States

**Facility:** Texas Center for Drug Development, Inc.

**State:** Texas

**Zip:** 77081

**Location 51:**

**City:** Plano

**Country:** United States

**Facility:** Psychiatric Medical Associates

**State:** Texas

**Zip:** 75023

**Location 52:**

**City:** San Antonio

**Country:** United States

**Facility:** Clinical Trials of Texas, Inc.

**State:** Texas

**Zip:** 78229

**Location 53:**

**City:** San Antonio

**Country:** United States

**Facility:** Radient Research, Inc.

**State:** Texas

**Zip:** 78229

**Location 54:**

**City:** Murray

**Country:** United States

**Facility:** Radiant Research, Inc.

**State:** Utah

**Zip:** 84123

**Location 55:**

**City:** Woodstock

**Country:** United States

**Facility:** Neuropsychiatric Associates

**State:** Vermont

**Zip:** 05091

**Location 56:**

**City:** Herndon

**Country:** United States

**Facility:** NeuroScience, Inc.

**State:** Virginia

**Zip:** 20170

**Location 57:**

**City:** Seattle

**Country:** United States

**Facility:** Summitt Research Network(Seattle) LLC

**State:** Washington

**Zip:** 98104

#### Overall Officials

**Official 1:**

**Affiliation:** Sumitomo Pharma America, Inc.

**Name:** Dasotraline Medical Director

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-06-13

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1750464

- Type Abbrev: Prot

- Upload Date: 2020-06-17T09:29

- Date: 2019-06-20

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 492541

- Type Abbrev: SAP

- Upload Date: 2020-06-17T09:32

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000006963

- Term: Hyperphagia

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M5304

- Name: Bulimia

- Relevance: HIGH

- As Found: Binge Eating

- ID: M28641

- Name: Binge-Eating Disorder

- Relevance: HIGH

- As Found: Binge Eating Disorder

- ID: M26956

- Name: Bulimia Nervosa

- Relevance: LOW

- As Found: Unknown

- ID: M4380

- Name: Feeding and Eating Disorders

- Relevance: HIGH

- As Found: Eating Disorders

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10014

- Name: Hyperphagia

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002032

- Term: Bulimia

- ID: D000001068

- Term: Feeding and Eating Disorders

- ID: D000056912

- Term: Binge-Eating Disorder

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).

#### Event Groups

**Group ID:** EG000

**Title:** Dasotraline

**Deaths Num At Risk:** 528

**Description:** 4, 6, 8 mg flexibly dosed

**ID:** EG000

**Other Num Affected:** 295

**Other Num at Risk:** 528

**Serious Number Affected:** 21

**Serious Number At Risk:** 528

**Title:** Dasotraline

**Frequency Threshold:** 5

#### Other Events

**Term:** Dry mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 19.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

**Term:** Irritability

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Iron deficiency anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Abdominal adhesions

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Localised infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Laceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Lumbar vertebral fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Post procedural inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Uterine leiomyoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Hemiplegic migraine

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Partial seizures

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Seizure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Panic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Paranoia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Psychotic disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Substance-induced mood disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Suicide attempt

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Term:** Menorrhagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 19.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 528

**Num Events:** 1

**Time Frame:** An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 528

**Units:** Participants

### Group

**ID:** BG000

**Title:** Dasotraline

**Description:** 4, 6, 8 mg flexibly dosed

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 526

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.81

**Value:** 38.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 440

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 88

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 85

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 443

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 14

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 82

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 420

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 11

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.77

**Value:** 167.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 21.52

**Value:** 95.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.348

**Value:** 33.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.54

**Value:** 4.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.38

**Value:** 2.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.522

**Value:** 3.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.007

**Value:** 2.21

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.721

**Value:** 4.38

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.655

**Value:** 4.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.687

**Value:** 2.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.961

**Value:** 1.71

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.944

**Value:** 3.44

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.912

**Value:** 3.55

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 53

**Class Title:** Underweight/Normal (<25)

#### Measurement

**Group ID:** BG000

**Value:** 104

**Class Title:** Overweight (25 to <30)

#### Measurement

**Group ID:** BG000

**Value:** 134

**Class Title:** Obesity Class I (30 to <35)

#### Measurement

**Group ID:** BG000

**Value:** 136

**Class Title:** Obesity Class II (35 to <40)

#### Measurement

**Group ID:** BG000

**Value:** 101

**Class Title:** Obesity Class III (>=40)

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Height (cm)
**Unit of Measure:** cm
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight (kg)
**Unit of Measure:** kg
### Measure 8
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** BMI (kg/m^2)
**Unit of Measure:** kg/m^2
### Measure 9
**Description:** DB Baseline (ie, Baseline assessment of the double-blind core studies \[SEP 360-221, or SEP360-321\]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Double-Blind (DB) Baseline
**Unit of Measure:** Score
### Measure 10
**Description:** The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study \[SEP 360-322\] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies \[SEP 360-221, or SEP 360-321\], otherwise).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Open Label (OL) Baseline
**Unit of Measure:** Score
### Measure 11
**Description:** DB Baseline (ie, Baseline assessment of the double-blind core studies \[SEP 360-221, or SEP360-321\]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Global Score
**Unit of Measure:** Score
### Measure 12
**Description:** DB Baseline (ie, Baseline assessment of the double-blind core studies \[SEP 360-221, or SEP360-321\]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Restraint
**Unit of Measure:** Score
### Measure 13
**Description:** DB Baseline (ie, Baseline assessment of the double-blind core studies \[SEP 360-221, or SEP360-321\]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Shape Concern
**Unit of Measure:** Score
### Measure 14
**Description:** DB Baseline (ie, Baseline assessment of the double-blind core studies \[SEP 360-221, or SEP360-321\]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** EDE-QM Modified Score at DB Baseline - Weight Concern
**Unit of Measure:** Score
### Measure 15
**Description:** The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study \[SEP 360-322\] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies \[SEP 360-221, or SEP 360-321\], otherwise).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** EDE-QM Modified Score at OL Baseline - Global Score
**Unit of Measure:** Score
### Measure 16
**Description:** The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study \[SEP 360-322\] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies \[SEP 360-221, or SEP 360-321\], otherwise).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** EDE-QM Modified Score at OL Baseline - Restraint
**Unit of Measure:** Score
### Measure 17
**Description:** The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study \[SEP 360-322\] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies \[SEP 360-221, or SEP 360-321\], otherwise).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** EDE-QM Modified Score at OL Baseline - Shape Concern
**Unit of Measure:** Score
### Measure 18
**Description:** The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study \[SEP 360-322\] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies \[SEP 360-221, or SEP 360-321\], otherwise).
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Eating Disorder Examination Question(EDE-QM) Modified Score at OL Baseline - Weight Concern
**Unit of Measure:** Score
### Measure 19
**Description:** The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study \[SEP 360-322\] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies \[SEP 360-221, or SEP 360-321\], otherwise).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** summary for Body Mass Index (BMI) category at open label baseline
**Unit of Measure:** Participants
**Population Description:** safety
## Results Section - More Information Module
### Certain Agreement
**Other Details:** In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialDisclosure@sunovion.com
**Organization:** Sunovion Pharmaceuticals Inc.
**Phone:** 1-866-503-6351
**Title:** CNS Medical Director
## 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
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 515
**Title:** 0: No suicidal ideation
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 1: Wish to be dead
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 2: Non-specific active suicidal thoughts
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 3: ideation with any methods , no intent to act
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 4: ideation with some intent to act, no plan
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 5: Active ideation with specific plan and intent
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.36
- **Spread:** 
- **Upper Limit:** -3.93
- **Value:** -4.65
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.77
- **Spread:** 
- **Upper Limit:** -1.49
- **Value:** -2.13
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.35
- **Spread:** 
- **Upper Limit:** -3.95
- **Value:** -4.65
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.71
- **Spread:** 
- **Upper Limit:** -1.43
- **Value:** -2.07
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.89
- **Spread:** 
- **Upper Limit:** -1.39
- **Value:** -1.64
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.97
- **Spread:** 
- **Upper Limit:** -0.53
- **Value:** -0.75
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.35
- **Spread:** 
- **Upper Limit:** -3.95
- **Value:** -4.65
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.71
- **Spread:** 
- **Upper Limit:** -1.43
- **Value:** -2.07
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -17.5
- **Spread:** 
- **Upper Limit:** -6.3
- **Value:** -11.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -10.4
- **Spread:** 
- **Upper Limit:** -0.3
- **Value:** -5.3
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -9.3
- **Spread:** 
- **Upper Limit:** -4.8
- **Value:** -7.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.6
- **Spread:** 
- **Upper Limit:** -1.4
- **Value:** -3.5
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.0
- **Spread:** 
- **Upper Limit:** -0.2
- **Value:** -1.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 1.9
- **Value:** 1.1
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.5
- **Spread:** 
- **Upper Limit:** -1.6
- **Value:** -3.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.2
- **Spread:** 
- **Upper Limit:** -1.5
- **Value:** -3.4
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.02
- **Spread:** 
- **Upper Limit:** 0.02
- **Value:** 0.00
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.02
- **Spread:** 
- **Upper Limit:** 0.02
- **Value:** 0.00
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.9
- **Spread:** 
- **Upper Limit:** 3.5
- **Value:** 2.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 3.1
- **Value:** 1.7
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.30
- **Spread:** 
- **Upper Limit:** -1.02
- **Value:** -1.16
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.48
- **Spread:** 
- **Upper Limit:** -0.26
- **Value:** -0.37
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.81
- **Spread:** 
- **Upper Limit:** -0.45
- **Value:** -0.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.27
- **Spread:** 
- **Upper Limit:** 0.01
- **Value:** -0.13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.54
- **Spread:** 
- **Upper Limit:** -1.22
- **Value:** -1.38
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.57
- **Spread:** 
- **Upper Limit:** -0.31
- **Value:** -0.44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.63
- **Spread:** 
- **Upper Limit:** -1.31
- **Value:** -1.47
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.66
- **Spread:** 
- **Upper Limit:** -0.39
- **Value:** -0.53
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -18.2
- **Spread:** 
- **Upper Limit:** -16.6
- **Value:** -17.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.6
- **Spread:** 
- **Upper Limit:** -3.1
- **Value:** -3.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -17.4
- **Spread:** 
- **Upper Limit:** -15.8
- **Value:** -16.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.2
- **Spread:** 
- **Upper Limit:** -2.8
- **Value:** -3.5
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -15.9
- **Spread:** 
- **Upper Limit:** -14.7
- **Value:** -15.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.8
- **Spread:** 
- **Upper Limit:** -2.7
- **Value:** -3.3
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.8
- **Spread:** 
- **Upper Limit:** -2.6
- **Value:** -2.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.8
- **Spread:** 
- **Upper Limit:** -0.5
- **Value:** -0.7
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -9.0
- **Spread:** 
- **Upper Limit:** -7.4
- **Value:** -8.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.1
- **Spread:** 
- **Upper Limit:** -0.9
- **Value:** -1.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.3
- **Spread:** 
- **Upper Limit:** -1.8
- **Value:** -2.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.6
- **Spread:** 
- **Upper Limit:** -0.2
- **Value:** -0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.5
- **Spread:** 
- **Upper Limit:** -2.9
- **Value:** -3.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.7
- **Spread:** 
- **Upper Limit:** -0.3
- **Value:** -0.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.2
- **Spread:** 
- **Upper Limit:** -2.6
- **Value:** -2.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.6
- **Spread:** 
- **Upper Limit:** -0.2
- **Value:** -0.4
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 0.9
- **Value:** 0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 1.0
- **Value:** 0.6
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.1
- **Spread:** 
- **Upper Limit:** -0.1
- **Value:** -0.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 0.8
- **Value:** 0.4
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.44
- **Spread:** 
- **Upper Limit:** 2.95
- **Value:** 1.25
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.27
- **Spread:** 
- **Upper Limit:** -0.40
- **Value:** -1.84
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.32
- **Spread:** 
- **Upper Limit:** 3.80
- **Value:** 2.56
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.16
- **Spread:** 
- **Upper Limit:** 1.90
- **Value:** 0.87
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety- please note:

one subject had no value for Suicidal Ideation or Suicidal Behavior
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 52
**Title:** Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 2
**Description:** Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline to Week 52
**Title:** Frequency and Severity of Suicidal Behavior Using the C-SSRS
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 3
**Description:** Change in body weight
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Body Weight
**Type:** SECONDARY
**Unit of Measure:** kg
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 4
**Description:** Percent change in body weight (kg)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Percent Change in Body Weight (kg)
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 5
**Description:** Change in Body Mass Index
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Body Mass Index
**Type:** SECONDARY
**Unit of Measure:** kg/m^2
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 6
**Description:** Percent change in Body Mass Index (kg/m\^2)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Percent Change in Body Mass Index (kg/m^2)
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 7
**Description:** Change in fasting lipid panel, Triglyceride's
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Fasting Lipid Panel, Triglyceride's
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 8
**Description:** Change in fasting lipid panel , total cholesterol
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Fasting Lipid Panel , Total Cholesterol
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 9
**Description:** Change in fasting lipid panel, high-density lipoprotein \[HDL\] cholesterol,
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 10
**Description:** Change in fasting lipid panel, low-density lipoprotein \[LDL\] cholesterol)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 11
**Description:** Change in hemoglobin A1c levels
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Hemoglobin A1c Levels
**Type:** SECONDARY
**Unit of Measure:** Percent change
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 12
**Description:** Change in fasting glucose levels
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Fasting Glucose Levels
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 13
**Description:** Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 14
**Description:** Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.

Item 4: Over the past 28 days, how many times have you eaten what other people would regard as an unusually large amount of food (given the circumstances)?

Item 5: On how many of these times did you have a sense of having lost control over your eating (at the time that you were eating)?
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores
**Type:** SECONDARY
**Unit of Measure:** events
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 15
**Description:** Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.

Item 6: Over the past 28 days, on how many DAYS have such episodes of overeating occurred (i.e., you have eaten an unusually large amount of food and have had a sense of loss of control at the time)?
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores
**Type:** SECONDARY
**Unit of Measure:** number of days
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 16
**Description:** Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 17
**Description:** The Sheehan Disability Scale (SDS) 3 subscales (work/school, social life, home life) are rated on the following scale: 0 = not at all; 1-3 = mildly; 4-6 = moderately; 7-9 =markedly; 10 = extremely. The 3 items can be combined into a single global measure of impairment (SDS total score) that ranges from 0 (unimpaired) to 30 (highly impaired). A higher subscale score and total score are associated with greater illness severity.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 18
**Description:** Hamilton Anxiety Rating Scale (HAM-A) total score HAM-A total score ranges from 0 to 56. A higher score is associated with a greater degree of anxiety.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 19
**Description:** Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
#### Outcome Measure 20
**Description:** Change in SF-12 two component scores (physical, mental health) for Subjects Continued from Study SEP360-221 The SF-12 is a 12-item self-report questionnaire. Physical Component Summary (PCS) and Mental Component Summary (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Safety
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 52
**Title:** Change in SF-12 Two Component Scores (Physical, Mental Health)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** OG000
**Title:** Dasotraline
### Participant Flow Module
#### Group
**Description:** 4, 6, 8 mg flexibly dosed
**ID:** FG000
**Title:** Dasotraline
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 87
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 61
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 92
##### Withdraw
**Type:** non-compliance with study drug
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
##### Withdraw
**Type:** non compliance with study visits
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** subject to have surgery
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** family emergency
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Site closures
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 528
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 249
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 279
**Pre-Assignment Details:** A total 533 subjects were enrolled in this study. Five subjects did not receive any dose of study medication.
**Has Results:** True