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A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

NCT03460756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-08-18

Study results available
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Summary

A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression

Conditions

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

Interventions

DRUG

Ganaxolone

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joseph Hulihan, MD · Marinus Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2019-07-05
Completion
2019-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03460756 on ClinicalTrials.gov