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
Ganaxolone for Post-Partum Depression
Sponsor: Marinus Pharmaceuticals
Enrolling: Female Patients Only
Study Length: 7 Days
Clinic Visits: 6
IRB Number: 7590
U.S. Govt. ID: NCT03228394
Contact: Peter Arden: 646-774-8004 / peter.arden@nyspi.columbia.edu
Additional Study Information: This is a pre-marketing (Phase 2A) multi-site study of an investigational drug, ganaxolone, as a potential treatment for non-psychotic post-partum depression. Eligible subjects who agree by signing informed consent will spend four days on the 5-South Research Unit (5-S) of the New York State Psychiatric Institute. For 6 hours they will have an tube in a vein into which randomly assigned intravenous ganaxolone or placebo will be infused. Mood and adverse events will be assessed throughout their 5-S stay and at weeks 1, 2, 3 and 4. Cohort #1 (9 patients), Cohort #2 (12 patients) and Cohort #3 (13 patients) have completed. Their lack of adverse reactions (side effects) determined that optional dose ranging Cohorts #4 & #5 could be skipped and Cohort #6 can begin recruitment of up to 20 subjects. Furthermore, ganaxolone has shown efficacy in oral formulation for other disorders so is an active compound with which there is considerable human experience. Nevertheless, this on-going study is its first use in post-partum women.
This study is closed
David Hellerstein, MD
Do You Qualify?
Have you given birth in the past year? Yes No
Are you currently pregnant or planning on becoming pregnant within the next month? Yes No
Would you be willing not to breastfeed through the duration of the study? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Peter Arden