NCT03228394

A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study will explore whether ganaxolone is safe and well tolerated in women suffering from PPD. In addition, ganaxolone's efficacy in treating depressive symptoms will be assessed through a set of exploratory analyses. Plasma levels of ganaxolone will be determined through pharmacokinetic analysis. The study results will be used to select a ganaxolone dose and dosing regimen for further development in PPD.

Conditions

• Depression
• Depressive Disorder
• Depression, Postpartum
• Behavioral Symptoms
• Mood Disorders
• Mental Disorders
• Puerperal Disorders
• Pregnancy Complications
• Postpartum
• PPD

Interventions

Type	Name	Description
DRUG	Ganaxolone	Ganaxolone IV
DRUG	Placebo	Placebo IV

Timeline

• Start date: 2017-06-27
• Primary completion: 2019-05-10
• Completion: 2020-05-10
• First posted: 2017-07-24
• Last updated: 2023-07-19
• Results posted: 2023-02-08

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study