A Clinical Trial of Intravenous 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 - 45
Updated:	10/4/2018
Start Date:	June 27, 2017
End Date:	June 30, 2019
Contact:	Jaakko Lappalainen, MD, PhD
Email:	jlappalainen@marinuspharma.com
Phone:	484 801 4678

A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression

This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of
Ganaxolone in Women with Postpartum Depression

Inclusion Criteria:

- Subject 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 7.0 interview

- Subject gave birth in the last 6 months

- Subject has a HAMD17 score of ≥ 26 at screening

- Subject 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 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

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A Clinical Trial of Intravenous Ganaxolone in Women With Postpartum Depression

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A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression

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