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

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

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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