Trial · NCT02684279
Dasotraline Binge Eating Disorder Extension Study
NCT02684279, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2020-08-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasotraline Binge Eating Disorder Extension Study. Trials, record NCT02684279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684279
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasotraline Binge Eating Disorder Extension Study
- NCT number
- NCT02684279
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 533 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Binge Eating Disorder
- Interventions
- Dasotraline
- First posted
- 2016-02-17
- Last updated
- 2020-08-12
- Results first posted
- 2020-08-12
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Baseline to Week 52 | 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 |
| Primary | Frequency and Severity of Suicidal Behavior Using the C-SSRS | Baseline to Week 52 | 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 |
| Secondary | Change in Body Weight | Baseline, Week 52 | Change in body weight |
| Secondary | Percent Change in Body Weight (kg) | Baseline, Week 52 | Percent change in body weight (kg) |
| Secondary | Change in Body Mass Index | Baseline, Week 52 | Change in Body Mass Index |
| Secondary | Percent Change in Body Mass Index (kg/m^2) | Baseline, Week 52 | Percent change in Body Mass Index (kg/m\^2) |
| Secondary | Change in Fasting Lipid Panel, Triglyceride's | Baseline, Week 52 | Change in fasting lipid panel, Triglyceride's |
| Secondary | Change in Fasting Lipid Panel , Total Cholesterol | Baseline, Week 52 | Change in fasting lipid panel , total cholesterol |
| Secondary | Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, | Baseline, Week 52 | Change in fasting lipid panel, high-density lipoprotein \[HDL\] cholesterol, |
| Secondary | Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) | Baseline, Week 52 | Change in fasting lipid panel, low-density lipoprotein \[LDL\] cholesterol) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Baseline to Week 52 | Safety- please note:~one subject had no value for Suicidal Ideation or Suicidal Behavior | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Frequency and Severity of Suicidal Behavior Using the C-SSRS | Baseline to Week 52 | Safety | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Body Weight | Baseline, Week 52 | Safety | kg | MEAN |
| SECONDARY | Percent Change in Body Weight (kg) | Baseline, Week 52 | Safety | percent change | MEAN |
| SECONDARY | Change in Body Mass Index | Baseline, Week 52 | Safety | kg/m^2 | MEAN |
| SECONDARY | Percent Change in Body Mass Index (kg/m^2) | Baseline, Week 52 | Safety | percent change | MEAN |
| SECONDARY | Change in Fasting Lipid Panel, Triglyceride's | Baseline, Week 52 | Safety | mg/dL | MEAN |
| SECONDARY | Change in Fasting Lipid Panel , Total Cholesterol | Baseline, Week 52 | Safety | mg/dL | MEAN |
| SECONDARY | Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, | Baseline, Week 52 | Safety | mg/dL | MEAN |
| SECONDARY | Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) | Baseline, Week 52 | Safety | mg/dL | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Dasotraline | 0: No suicidal ideation | 515 | Participants | |
| Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Dasotraline | 1: Wish to be dead | 7 | Participants | |
| Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Dasotraline | 2: Non-specific active suicidal thoughts | 3 | Participants | |
| Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Dasotraline | 3: ideation with any methods , no intent to act | 1 | Participants | |
| Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Dasotraline | 4: ideation with some intent to act, no plan | 0 | Participants | |
| Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Dasotraline | 5: Active ideation with specific plan and intent | 1 | Participants | |
| Frequency and Severity of Suicidal Behavior Using the C-SSRS | Dasotraline | Preparatory acts or behavior | 1 | Participants | |
| Frequency and Severity of Suicidal Behavior Using the C-SSRS | Dasotraline | Aborted attempt | 0 | Participants | |
| Frequency and Severity of Suicidal Behavior Using the C-SSRS | Dasotraline | Interrupted attempt | 0 | Participants | |
| Frequency and Severity of Suicidal Behavior Using the C-SSRS | Dasotraline | Actual attempt | 1 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasotraline | 528 | |
| Overall Study | COMPLETED | Dasotraline | 249 | |
| Overall Study | NOT COMPLETED | Dasotraline | 279 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Dasotraline | 73 | 528 | 81 |
| other | Nausea | Gastrointestinal disorders | Dasotraline | 27 | 528 | 30 |
| other | Nasopharyngitis | Infections and infestations | Dasotraline | 30 | 528 | 39 |
| other | Upper respiratory tract infection | Infections and infestations | Dasotraline | 51 | 528 | 69 |
| other | Weight decreased | Investigations | Dasotraline | 77 | 528 | 96 |
| other | Headache | Nervous system disorders | Dasotraline | 52 | 528 | 60 |
| other | Anxiety | Psychiatric disorders | Dasotraline | 70 | 528 | 77 |
| other | Insomnia | Psychiatric disorders | Dasotraline | 103 | 528 | 114 |
| other | Irritability | Psychiatric disorders | Dasotraline | 27 | 528 | 28 |
| serious | Anaemia | Blood and lymphatic system disorders | Dasotraline | 1 | 528 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasotraline | 0 | 528 |
| Total, other adverse events | Dasotraline | 295 | 528 |
| Total, serious adverse events | Dasotraline | 21 | 528 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02684279
GET https://conductscience.org/api/trials/v1/NCT02684279/results?page=2