A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
NCT ID: NCT03460756
Last Updated: 2023-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2017-12-28
2019-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ganaxolone
Oral
Ganaxolone
Oral
Placebo
Oral
Placebo
Oral
Interventions
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Ganaxolone
Oral
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* 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
* History of suicide attempt within the past 3 years
* History of bipolar I disorder
* History of seizure discorder
18 Years
48 Years
FEMALE
No
Sponsors
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Marinus Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Hulihan, MD
Role: STUDY_DIRECTOR
Marinus Pharmaceuticals
Locations
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Marinus Research Site
Glendale, California, United States
Marinus Research Site
Lemon Grove, California, United States
Marinus Research Site
Long Beach, California, United States
Marinus Research Site
Oceanside, California, United States
Marinus Research Site
Panorama City, California, United States
Marinus Research Site
San Bernardino, California, United States
Marinus Research Site
San Marcos, California, United States
Marinus Research Site
Ventura, California, United States
Marinus Research Site
Gainesville, Florida, United States
Marinus Research Site
Hollywood, Florida, United States
Marinus Research Site
Jacksonville, Florida, United States
Marinus Research Site
North Miami, Florida, United States
Marinus Research Site
Atlanta, Georgia, United States
Marinus Research Site
Atlanta, Georgia, United States
Marinus Research Site
Decatur, Georgia, United States
Marinus Research Site
Marietta, Georgia, United States
Marinus Research Site
Idaho Falls, Idaho, United States
Marinus Research Site
Hoffman Estates, Illinois, United States
Marinus Research Site
Leawood, Kansas, United States
Marinus Research Site
Wichita, Kansas, United States
Marinus Research Site
Flowood, Mississippi, United States
Marinus Research Site
Las Vegas, Nevada, United States
Marinus Research Site
Albuquerque, New Mexico, United States
Marinus Research Site
Raleigh, North Carolina, United States
Marinus Research Site
Englewood, Ohio, United States
Marinus Research Site
Downingtown, Pennsylvania, United States
Marinus Research Site
Media, Pennsylvania, United States
Marinus Research Site
Houston, Texas, United States
Marinus Research Site
Irving, Texas, United States
Marinus Research Site
League City, Texas, United States
Marinus Research Site
San Antonio, Texas, United States
Marinus Research Site
Orem, Utah, United States
Marinus Research Site
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1042-PPD-2003
Identifier Type: -
Identifier Source: org_study_id
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