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A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03228394•Marinus Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participant experienced a Major Depressive Episode, which started between the start of the third trimester and 4 weeks following delivery. The Major Depressive Episode must be diagnosed according to Mini International Neuropsychiatric Interview (MINI) 7.0 interview
•Participant gave birth in the last 6 months
•Participant has a Hamilton Depression Rating Scale 17-item version (HAMD17) score of ≥ 26 at screening
•Participant must agree to stop breastfeeding from start of study treatment or must agree to temporarily cease giving breast milk to her infant(s)

Exclusion Criteria

•Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features
•History of suicide attempt within the past 3 years
•Active suicidal ideation
•History of bipolar I disorder
•History of seizure disorder

Locations (16)

Marinus Research Site

Little Rock, Arkansas, United States

Marinus Research Site

Costa Mesa, California, United States

Marinus Research Site

Lemon Grove, California, United States

Marinus Research Site

San Diego, California, United States

Marinus Research Site

Jacksonville, Florida, United States

Marinus Research Site

Atlanta, Georgia, United States

Marinus Research Site

Decatur, Georgia, United States

Marinus Research Site

Leawood, Kansas, United States

Marinus Research Site

Overland Park, Kansas, United States

Marinus Research Site

New York, New York, United States

Key Dates

Start Date

June 27, 2017

Primary Completion Date

May 10, 2019

Completion Date

May 10, 2020

Last Updated

July 19, 2023

Enrollment

ACTUAL participants

Conditions

DepressionDepressive DisorderDepression, PostpartumBehavioral SymptomsMood DisordersMental DisordersPuerperal DisordersPregnancy ComplicationsPostpartumPPD

Interventions

Ganaxolone

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

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