RecruitMe Clinical Trial

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
Age Range:Between 18 and 45 years old
IRB Number:7590
U.S. Government 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 60 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. The initial cohort of 10 patients have completed. their lack of adverse reactions (side effects) determined that the second cohort of 10 will receive a higher dose. Results in this second cohort will determine ganaloxone dose for the final 10 subjects.The rationale for this study is that because of ganaxolone's close similarity to a breakdown product of progesterone called allopregnanolone, it will counteract the sudden decrease of allopregnanolone which begins to occur about a month prior to delivery, but precipitously at delivery possibly accounting for the onset of peri-partum depression. Both allopregnanolone and ganaxolone are known to affect brain receptors long thought important in anxiety disorders (the pharmacologic mumbo jumbo is that ganaxolone and allopregnanolone modulate GABAA which along with the benzodiazepine receptor is part of the NMDA complex). As these same brain receptors are the site of ketamine's action, they also seem important for some depressive disorders. Thus, modulating GABAA with ganaxolone might result in rapid antidepressant effect in post-partum depression, as ketamine does in some non-post-partum depressions. While this is the first use of ganaxolone for this purpose, a recent nearly identical study of its natural analogue, allopregnanolone, showed efficacy relative to intravenous placebo.

This study is closed
Investigator
David Hellerstein, MD
You may be eligible for this study

Place Holder




Who Can I Contact?
For more information, please contact:

Peter Arden

peter.arden@nyspi.columbia.edu

646-774-8004

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