A Clinical Trial of Intravenous Ganaxolone in Women With Postpartum Depression

• Status: Completed
• Trial end date: 2020-05-10
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marinus Pharmaceuticals
• Treatments: Ganaxolone; Pregnanolone

Criteria

Inclusion Criteria:

• Subject 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 7.0 interview

• Subject gave birth in the last 6 months

• Subject has a HAMD17 score of ≥ 26 at screening

• Subject 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