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Keep this study
Lead
Marinus Pharmaceuticals
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 exploratory analyses. Plasma levels of ganaxolone will be determined through pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and dosing regimen for further development in PPD.
Age
18–45
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features
History of suicide attempt within the past 3 years
