Status:
COMPLETED
A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Lead Sponsor:
Marinus Pharmaceuticals
Conditions:
Depressive Disorder
Depression
Eligibility:
FEMALE
18-48 years
Phase:
PHASE2
Brief Summary
A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03460756
Start Date
December 28 2017
End Date
July 5 2019
Last Update
August 18 2023
Active Locations (33)
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1
Marinus Research Site
Glendale, California, United States, 91206
2
Marinus Research Site
Lemon Grove, California, United States, 91945
3
Marinus Research Site
Long Beach, California, United States, 90806
4
Marinus Research Site
Oceanside, California, United States, 92056