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NCT02942004 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 138
- Enrollment target
NCT02942004: Completed Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT02942004 is a Phase 3 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 138 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02942004, a Phase 3 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 138 participants
- Enrollment target
Study Summary
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe 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
Interventions
- DRUG Placebo
- DRUG SAGE-547 90 μg/kg/h
- DRUG SAGE-547 60 μg/kg/h
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2017-10-19 |
| Phase | Phase 3 |
What the finished NCT02942004 record still lists
NCT02942004 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02942004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02942004 about?
NCT02942004 is a clinical study titled "A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)". The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from ...
What is the current status of trial NCT02942004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 138 participants. The study started on 2016-08-01. Estimated completion is 2017-10-19.
What interventions are being tested in trial NCT02942004?
The interventions under investigation include: Placebo (DRUG), SAGE-547 90 μg/kg/h (DRUG), SAGE-547 60 μg/kg/h (DRUG).
Who is sponsoring clinical trial NCT02942004?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02942004's enrollment target sits among peer trials
138 1577th of 2000 higher than 421 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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