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

NCT03228394 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2023-07-19

Study results available
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Summary

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

Conditions

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

Interventions

DRUG

Ganaxolone

Ganaxolone IV

DRUG

Placebo

Placebo IV

Sponsors & Collaborators

  • Marinus Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2019-05-10
Completion
2020-05-10
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 NCT03228394 on ClinicalTrials.gov