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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 is a Phase 3 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 138 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02942004
The ClinicalTrials.gov registry entry for NCT02942004 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02942004 reports 0 study locations.
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.
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