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

Trial Profile

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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 31 Oct 2017

At a glance

  • Drugs Ganaxolone (Primary)
  • Indications Postnatal depression
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms Magnolia
  • Sponsors Marinus Pharmaceuticals
  • Most Recent Events

    • 31 Oct 2017 According to a Marinus Pharmaceuticals media release, data is expected in 2018.
    • 01 Aug 2017 According to a Marinus Pharmaceuticals media release, the study consists of multiple cohorts of women with a Hamilton Depression Rating Scale (HAMD17) score =26. Patients randomized to the first study cohort will undergo an infusion of either ganaxolone or placebo and will be followed for at least 30 days. Subsequent cohorts could include shorter- or higher-dose IV regimens alone, or in sequential administration with ganaxolone capsules.
    • 27 Jun 2017 Status changed from planning to recruiting, according to a Marius Pharmaceuticals media release.
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