Phase 2 N=84 Randomized Quadruple-blind Treatment

A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression

Depressive Disorder · Depression · Depression, Postpartum · Behavioral Symptoms · Mood Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03460756 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Jan 2023

Primary outcome: Primary: Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment — -8.0; -5.7; -0.8; -2.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ganaxolone (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Marinus Pharmaceuticals
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment	-8.0; -5.7; -0.8; -2.6; -15.0; -6.7	—
SECONDARY Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment	-19.0; -7.1; -14.6; -12.4; -13.2; -12.3	—
SECONDARY Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)	0; 2; 0; 3; 1; 4	—
SECONDARY Number of Participants With Hamilton Depression Rating Scale 17-item Remission	0; 1; 1; 8; 0; 2	—
SECONDARY Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score	-0.5; -1.4; -0.8; -0.6; -2.0; -2.3	—
SECONDARY Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version	-11.7; -6.4; -1.8; -9.9; -11.7; -9.0	—
SECONDARY Number of Participants With Clinical Global Impression-Improvement	0; 1; 1; 4; 1; 6	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03460756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.