Clinical trial NCT03228394: A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
Official title: A Phase 2A, Double-blind, Placebo-controlled, Multiple-dose Escalation Study to Evaluate Safety, Pharmacokinetics and Efficacy of Intravenously Administered Ganaxolone in Women With Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Postpartum
PPD
Keywords: Postpartum Care
Postpartum Depression
Lead sponsor: Marinus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Change From Baseline in Hamilton Depression Rating Scale 17-item Version (HAMD17) Total Score
timeFrame: Baseline and Day 3 post-infusion (60 hours post start of infusion) for Cohorts 1 to 3 and Baseline and Day 29 for Cohort 6
Secondary outcomes:
measure: Change From Baseline in HAMD17 Total Score at Indicated Time Points
timeFrame: Baseline, Day1 post-infusion(6hours post start of infusion), Day1(12hours post start of infusion), Day2(24hours post start of infusion),Day3 post-infusion(48hours post start of infusion),Day4(72hours post start of infusion),Days 8,11,15,22,36,57 and 71
measure: Number of Participants With HAMD17 Response
timeFrame: Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day 2 (24 hours post SOI),Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,36,57 and 71
measure: Number of Participants With HAMD17 Remission
timeFrame: Day1 post-infusion (6 hours post start of infusion [SOI]), Day 1 (12 hours post SOI), Day2 (24 hours post SOI), Day 3 post-infusion (48 hours post SOI), Day 3 post-infusion (60 hours post SOI), Day 4 (72 hours post SOI), Days 8,11,15,22,29,34,57 and 71
measure: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) Total Score
timeFrame: Baseline, Day 1, Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71
measure: Change From Baseline in Spielberger State-Trait Anxiety Inventory 6-item Version (STAI6) Total Score
timeFrame: Baseline, Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71
measure: Number of Participants With Response to Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: Day 1 (12 hours post start of infusion), Day 2, Day 3 post-infusion (60 hours post start of infusion), Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 34, Day 36, Day 57 and Day 71
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Marinus Research Site
state: Arkansas
city: Costa Mesa
country: United States
facility: Marinus Research Site
state: California
city: Lemon Grove
country: United States
facility: Marinus Research Site
state: California
city: San Diego
country: United States
facility: Marinus Research Site
state: California
city: Jacksonville
country: United States
facility: Marinus Research Site
state: Florida
city: Atlanta
country: United States
facility: Marinus Research Site
state: Georgia
city: Decatur
country: United States
facility: Marinus Research Site
state: Georgia
city: Leawood
country: United States
facility: Marinus Research Site
state: Kansas
city: Overland Park
country: United States
facility: Marinus Research Site
state: Kansas
city: New York
country: United States
facility: Marinus Research Site
state: New York
city: Dayton
country: United States
facility: Marinus Research Site
state: Ohio
city: Houston
country: United States
facility: Marinus Research Site
state: Texas
city: Irving
country: United States
facility: Marinus Research Site
state: Texas
city: Orem
country: United States
facility: Marinus Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Marinus Research Site
state: Utah
city: Richmond
country: United States
facility: Marinus Research Site
state: Virginia
Study officials:
References: