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NCT02285504 · ClinicalTrials.gov registry record · Phase 2
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
A Phase 2 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02285504: Completed Phase 2 study, sponsored by Supernus Pharmaceuticals.
NCT02285504 is a Phase 2 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02285504, a Phase 2 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
Primary Outcome
AEs were any untoward medical occurrences in a participant who received study treatment without regard to possibility of causal relationship. TEAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 7 days after the end of infusion (Day 11). TESAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical con
Interventions
- DRUG SAGE-547
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-01-07 |
| Est. Completion | 2015-06-05 |
| Phase | Phase 2 |
What the finished NCT02285504 record still lists
NCT02285504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which SAGE-547 is the first listed.
NCT02285504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02285504 about?
NCT02285504 is a clinical study titled "Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression". This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
What is the current status of trial NCT02285504?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2015-01-07. Estimated completion is 2015-06-05.
What interventions are being tested in trial NCT02285504?
The interventions under investigation include: SAGE-547 (DRUG).
Who is sponsoring clinical trial NCT02285504?
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 NCT02285504's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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