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NCT03228394 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
A Phase 2 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT03228394: Completed Phase 2 study, sponsored by Marinus Pharmaceuticals.
NCT03228394 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03228394, a Phase 2 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression
Primary Outcome
The HAMD17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (8 items) or 0 and 2 (9 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items,
Interventions
- DRUG Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2017-06-27 |
| Est. Completion | 2020-05-10 |
| Phase | Phase 2 |
What the finished NCT03228394 record still lists
NCT03228394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03228394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03228394 about?
NCT03228394 is a clinical study titled "A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression". This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression
What is the current status of trial NCT03228394?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2017-06-27. Estimated completion is 2020-05-10.
What interventions are being tested in trial NCT03228394?
The interventions under investigation include: Placebo (DRUG), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT03228394?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03228394's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 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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