ClinicalTrials.Veeva

Menu

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

M

Marinus Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

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

Treatments

Drug: Placebo
Drug: Ganaxolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT03228394
1042-PPD-2002

Details and patient eligibility

About

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

Full 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.

Enrollment

91 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

91 participants in 2 patient groups, including a placebo group

Ganaxolone
Experimental group
Description:
Intravenous
Treatment:
Drug: Ganaxolone
Placebo
Placebo Comparator group
Description:
Intravenous
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

16

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems