A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

Marinus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pregnancy Complications; Mental Disorder; Postpartum Blues; PPD; Depression, Postpartum; Postpartum Disorder; Behavioral Symptoms; Depression; Mood Disorders; Depressive Disorder

Treatments: Drug: Ganaxolone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03460756

1042-PPD-2003

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Experiencing 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
• Given birth in the last 6 months
• HAMD17 score of ≥ 20 at screening but < 26
• 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 history of any psychotic illness, including major depressive episode with psychotic features
• History of suicide attempt within the past 3 years
• History of bipolar I disorder
• History of seizure discorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Ganaxolone

Experimental group

Description:

Oral

Treatment:

Drug: Ganaxolone

Placebo

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo