A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Status: | Recruiting |
---|---|
Conditions: | Depression, Depression, Psychiatric, Psychiatric, Psychiatric, Women's Studies |
Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
Healthy: | No |
Age Range: | 18 - 48 |
Updated: | 9/2/2018 |
Start Date: | December 28, 2017 |
End Date: | January 2019 |
Contact: | William Amerine |
Email: | wamerine@marinuspharma.com |
Phone: | 484-801-4676 |
A Phase 2, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Oral Administration of Ganaxolone in Women With Postpartum Depression
A clinical study to evaluate safety, tolerability and efficacy of oral administration of
ganaxolone in women with postpartum depression
ganaxolone in women with postpartum depression
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
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