Clinical trial NCT03460756: A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Official title: A Phase 2, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Oral Administration of Ganaxolone in Women With Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Depression
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorder
Pregnancy Complications
Postpartum Blues
PPD
Postpartum Disorder
Keywords: Postpartum Care
Postpartum Depression
Lead sponsor: Marinus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Through Treatment
timeFrame: Baseline (Day 1) and through Day 10 for 2 week treatment group and Day 29 for 4 week treatment groups
Secondary outcomes:
measure: Change From Baseline in Hamilton Depression Rating Scale 17-item Version Post Treatment
timeFrame: Baseline (Day 1) and Through Day 38 for 2 week treatment group and Day 71 and 119 for 4 week treatment groups
measure: Number of Participants With Response to Hamilton Depression Rating Scale 17 Item (HAMD17)
timeFrame: Day 2 (all treatment groups), Day 7 (TID & QHS), Day 8/10 (all treatment groups), Day 15/17 (all treatment groups), Day 22 and 29 (QHS, 1125mg), Day 36/38 (all treatment groups), Day 57/59 (QHS, 1125mg), Day 71 (1125mg), Day 89 (QHS), Day 119 (QHS)
measure: Number of Participants With Hamilton Depression Rating Scale 17-item Remission
timeFrame: Day 8/10 (all treatment arms), Day 15/17 (all treatment arms), Day 22 and 29 (QHS & 1125mg), Day 36/38 (all treatment arms), Day 57/59 (QHS & 1125mg), Day 71 (1125mg), Day 89 & 119 (QHS)
measure: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
timeFrame: Baseline (Day 1) through Day 119
measure: Change From Baseline in Spielberger State-Trait Anxiety Inventory, 6-item Version
timeFrame: Baseline (Day 1) through Day 119
measure: Number of Participants With Clinical Global Impression-Improvement
timeFrame: Baseline through Day 119
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Marinus Research Site
state: California
city: Lemon Grove
country: United States
facility: Marinus Research Site
state: California
city: Long Beach
country: United States
facility: Marinus Research Site
state: California
city: Oceanside
country: United States
facility: Marinus Research Site
state: California
city: Panorama City
country: United States
facility: Marinus Research Site
state: California
city: San Bernardino
country: United States
facility: Marinus Research Site
state: California
city: San Marcos
country: United States
facility: Marinus Research Site
state: California
city: Ventura
country: United States
facility: Marinus Research Site
state: California
city: Gainesville
country: United States
facility: Marinus Research Site
state: Florida
city: Hollywood
country: United States
facility: Marinus Research Site
state: Florida
city: Jacksonville
country: United States
facility: Marinus Research Site
state: Florida
city: North Miami
country: United States
facility: Marinus Research Site
state: Florida
city: Atlanta
country: United States
facility: Marinus Research Site
state: Georgia
city: Atlanta
country: United States
facility: Marinus Research Site
state: Georgia
city: Decatur
country: United States
facility: Marinus Research Site
state: Georgia
city: Marietta
country: United States
facility: Marinus Research Site
state: Georgia
city: Idaho Falls
country: United States
facility: Marinus Research Site
state: Idaho
city: Hoffman Estates
country: United States
facility: Marinus Research Site
state: Illinois
city: Leawood
country: United States
facility: Marinus Research Site
state: Kansas
city: Wichita
country: United States
facility: Marinus Research Site
state: Kansas
city: Flowood
country: United States
facility: Marinus Research Site
state: Mississippi
city: Las Vegas
country: United States
facility: Marinus Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Marinus Research Site
state: New Mexico
city: Raleigh
country: United States
facility: Marinus Research Site
state: North Carolina
city: Englewood
country: United States
facility: Marinus Research Site
state: Ohio
city: Downingtown
country: United States
facility: Marinus Research Site
state: Pennsylvania
city: Media
country: United States
facility: Marinus Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Marinus Research Site
state: Texas
city: Irving
country: United States
facility: Marinus Research Site
state: Texas
city: League City
country: United States
facility: Marinus Research Site
state: Texas
city: San Antonio
country: United States
facility: Marinus Research Site
state: Texas
city: Orem
country: United States
facility: Marinus Research Site
state: Utah
city: Richmond
country: United States
facility: Marinus Research Site
state: Virginia
Study officials:
affiliation: Marinus Pharmaceuticals
name: Joseph Hulihan, MD
role: STUDY_DIRECTOR
References: