A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

• Status: Completed
• Trial end date: 2019-07-05
• Target enrollment: 0
• Participant gender: Female

Summary

A clinical study to evaluate safety, tolerability and efficacy of oral 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:

• Experiencing 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

• Given birth in the last 6 months

• HAMD17 score of ≥ 20 at screening but < 26

• 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 history of any psychotic illness, including major depressive episode with psychotic features

• History of suicide attempt within the past 3 years

• History of bipolar I disorder

• History of seizure discorder