Status:
COMPLETED
A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
Lead Sponsor:
Marinus Pharmaceuticals
Conditions:
Depression
Depressive Disorder
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression
Detailed Description
This study will explore whether ganaxolone is safe and well tolerated in women suffering from PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed through a set of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2020
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03228394
Start Date
June 27 2017
End Date
May 10 2020
Last Update
July 19 2023
Active Locations (16)
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1
Marinus Research Site
Little Rock, Arkansas, United States, 72211
2
Marinus Research Site
Costa Mesa, California, United States, 92626
3
Marinus Research Site
Lemon Grove, California, United States, 91945
4
Marinus Research Site
San Diego, California, United States, 92103