A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression



Status:Recruiting
Conditions:Depression, Depression, Psychiatric, Psychiatric, Psychiatric, Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - 48
Updated:9/2/2018
Start Date:December 28, 2017
End Date:January 2019
Contact:William Amerine
Email:wamerine@marinuspharma.com
Phone:484-801-4676

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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

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


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
We found this trial at
27
sites
Decatur, Georgia 30030
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Decatur, GA
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Albuquerque, New Mexico 87102
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Albuquerque, NM
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501 Fairburn Road Southwest
Atlanta, Georgia 30331
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Atlanta, GA
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Downingtown, Pennsylvania 19335
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Downingtown, PA
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Englewood, Ohio 45322
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Englewood, OH
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Gainesville, Florida 32607
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Gainesville, FL
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Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Hollywood, Florida 33021
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Hollywood, FL
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Houston, Texas 77058
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Houston, TX
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Idaho Falls, Idaho 83404
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Idaho Falls, ID
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Irving, Texas 75062
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Irving, TX
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Jacksonville, Florida 32216
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Jacksonville, FL
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Leawood, Kansas 66206
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Leawood, KS
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Lemon Grove, California 91945
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Lemon Grove, CA
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Long Beach, California 90806
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Long Beach, CA
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Marietta, Georgia 30060
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Marietta, GA
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Media, Pennsylvania 19063
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Media, PA
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North Miami, Florida 33161
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North Miami, FL
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Oceanside, California 92056
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Oceanside, CA
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Orem, Utah 84058
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Orem, UT
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Panorama City, California 91402
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Panorama City, CA
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Richmond, Virginia 23298
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Richmond, VA
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San Antonio, Texas 78229
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San Antonio, TX
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San Bernardino, California 92408
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San Bernardino, CA
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San Marcos, California 92078
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San Marcos, CA
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Ventura, California 93003
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Ventura, CA
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