At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
Ganaxolone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression
In Brief
A Phase 2 clinical trial evaluating Ganaxolone and Placebo for Depression and 9 related conditions. Completed, enrolled 91 participants across 16 sites.
Detailed Summary
This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Depressive Disorder, Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorders, Puerperal Disorders, Pregnancy Complications, Postpartum, PPD
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJul 2017
Primary CompletionMay 2019
Study CompletionMay 2020
TodayJul 2026
First PostedJul 24, 2017
Enrollment StartJun 27, 2017
Primary CompletionMay 10, 2019
Study CompletionMay 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.9 years ago
Interventions
Ganaxolonedrug
Ganaxolone IV
Placebodrug
Placebo IV