CompletedPhase 2

A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression

United States91 participantsStarted 2017-06-27

Plain-language summary

This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant experienced a Major Depressive Episode, which started between the start of the third trimester and 4 weeks following delivery. The Major Depressive Episode must be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0 interview * Participant gave birth in the last 6 months * Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥ 26 at screening * Participant must agree to stop breastfeeding from start of study treatment or must agree to temporarily cease giving breast milk to her infant(s) Exclusion Criteria: * Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features * History of suicide attempt within the past 3 years * Active suicidal ideation * History of bipolar I disorder * History of seizure disorder

What they're measuring

Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score

Timeframe: Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6

Trial details

NCT IDNCT03228394

SponsorMarinus Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-10

Results submitted2022-05-24

View on ClinicalTrials.gov More Depression trials