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NCT02614547 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
A Phase 2 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT02614547: Completed Phase 2 study, sponsored by Supernus Pharmaceuticals.
NCT02614547 is a Phase 2 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02614547, a Phase 2 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-12-15 |
| Est. Completion | 2016-06-22 |
| Phase | Phase 2 |
What the finished NCT02614547 record still lists
NCT02614547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02614547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02614547 about?
NCT02614547 is a clinical study titled "A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression". This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.
What is the current status of trial NCT02614547?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2015-12-15. Estimated completion is 2016-06-22.
What interventions are being tested in trial NCT02614547?
The interventions under investigation include: Placebo (DRUG), SAGE-547 (DRUG).
Who is sponsoring clinical trial NCT02614547?
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 NCT02614547's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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