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

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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A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

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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

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