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NCT02978326 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
A Phase 3 study of Postpartum Depression, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
- 20
- Study locations
NCT02978326: Completed Phase 3 study of Postpartum Depression, sponsored by Biogen.
NCT02978326 is a Phase 3 study of Postpartum Depression that has completed, run by Biogen. The registered enrollment target is 276 participants, below the 469-participant average among 47 other Postpartum Depression trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02978326, a Phase 3 study of Postpartum Depression, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).
Primary Outcome
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total sc
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAGE-217 15/20 mg Oral Solution
- DRUG SAGE 217 30 mg Capsules
Study Locations (20)
Florida
- Sage Investigational Site - Aventura
- Sage Investigational Site - Miami
- Sage Investigational Site - Orlando
- Sage Investigational Site - Pensacola
- Sage Investigational SIte - Pinellas Park
California
- Sage Investigational Site - Beverly Hills
- Sage Investigational Site - Oceanside
- Sage Investigational Site - Wildomar
Georgia
- Sage Investigational Site - Atlanta
- Sage Investigational Site - Decatur
Louisiana
- Sage Investigational Site - Lake Charles
- Sage Investigational Site - New Orleans
New York
- Sage Investigational Site - Manhasset
- Sage Investigational Site - New York
Arkansas
- Sage Investigational Site - Little Rock
District of Columbia
- Sage Investigational Site - Washington D.C.
Illinois
- Sage Investigational Site - Hoffman Estates
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2017-01-04 |
| Est. Completion | 2018-12-11 |
| Phase | Phase 3 |
What the finished NCT02978326 record still lists
NCT02978326 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 469-participant average among 47 other Postpartum Depression trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02978326 names 20 study sites across 11 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02978326 about?
NCT02978326 is a clinical study titled "A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression". The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day...
What is the current status of trial NCT02978326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2017-01-04. Estimated completion is 2018-12-11.
What conditions does trial NCT02978326 study?
This clinical trial studies the following conditions: Postpartum Depression.
What interventions are being tested in trial NCT02978326?
The interventions under investigation include: Placebo (DRUG), SAGE-217 15/20 mg Oral Solution (DRUG), SAGE 217 30 mg Capsules (DRUG).
Who is sponsoring clinical trial NCT02978326?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02978326 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postpartum Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02978326's enrollment target sits among peer trials
276 15th of 47 higher than 33 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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