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NCT02942017 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
A Phase 3 study of Postpartum Depression, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT02942017: Completed Phase 3 study of Postpartum Depression, sponsored by Supernus Pharmaceuticals.
NCT02942017 is a Phase 3 study of Postpartum Depression that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 108 participants, below the 473-participant average among 47 other Postpartum Depression trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02942017, a Phase 3 study of Postpartum Depression, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.
Primary Outcome
The HAM-D Total Score comprises a sum of the 17 individual item scores. 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 Total Score can range from 0 to 52, and higher scores indic
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAGE-547 90 μg/kg/h
Study Locations (20)
Florida
- Sage Investigational Site - Gainesville
- Sage Investigational Site - Miami
- Sage Investigational Site - Miramar
- Sage Investigational Site - Orlando
- Sage Investigational Site - Pensacola
- Sage Investigational Site - Pinellas Park
California
- Sage Investigational Site - Lemon Grove
- Sage Investigational Site - Orange
- Sage Investigational Site - Ventura
Kentucky
- Sage Investigational Site - Edgewood
- Sage Investigational Site - Owensboro
Arizona
- Sage Investigational Site - Chandler
Arkansas
- Sage Investigational Site - Rogers
Georgia
- Sage Investigational Site - Atlanta
Illinois
- Sage Investigational Site - Hoffman Estates
Kansas
- Sage Investigational Site - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2016-07 |
| Est. Completion | 2017-10-11 |
| Phase | Phase 3 |
What the finished NCT02942017 record still lists
NCT02942017 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 473-participant average among 47 other Postpartum Depression trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02942017 names 20 study sites across 12 states, led by Florida, California, Kentucky.
Frequently Asked Questions
What is clinical trial NCT02942017 about?
NCT02942017 is a clinical study titled "A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)". The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale...
What is the current status of trial NCT02942017?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2016-07. Estimated completion is 2017-10-11.
What conditions does trial NCT02942017 study?
This clinical trial studies the following conditions: Postpartum Depression.
What interventions are being tested in trial NCT02942017?
The interventions under investigation include: Placebo (DRUG), SAGE-547 90 μg/kg/h (DRUG).
Who is sponsoring clinical trial NCT02942017?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02942017 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, 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 NCT02942017's enrollment target sits among peer trials
108 24th of 47 higher than 24 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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