Phase 2 N=91 Randomized Quadruple-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT03228394 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Feb 2023

Primary outcome: Primary: Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score — -13.0; -12.0; -14.0; -14.3 Scores 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: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score	-13.0; -12.0; -14.0; -14.3; -11.0; -11.3	—
SECONDARY Change From Baseline in HAMD17 Total Score at Indicated Time Points	-3.2; -6.1; -3.8; -2.4; -3.2; -2.7	—
SECONDARY Number of Participants With HAMD17 Response	2; 5; 0; 0; 1; 0	—
SECONDARY Number of Participants With HAMD17 Remission	0; 3; 0; 0; 0; 0	—
SECONDARY Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score	-1.9; -5.4; -4.9; -7.5; -8.8; -8.0	—
SECONDARY Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score	-8.9; -4.2; -14.5; -12.01; -10.7; -11.3	—
SECONDARY Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale	0; 0; 2; 3; 1; 0	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03228394). 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.