A Clinical Trial of Intravenous 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 - 45
Updated:10/4/2018
Start Date:June 27, 2017
End Date:June 30, 2019
Contact:Jaakko Lappalainen, MD, PhD
Email:jlappalainen@marinuspharma.com
Phone:484 801 4678

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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

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


Inclusion Criteria:

- Subject 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 7.0 interview

- Subject gave birth in the last 6 months

- Subject has a HAMD17 score of ≥ 26 at screening

- Subject 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
We found this trial at
16
sites
Overland Park, Kansas 66211
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501 Fairburn Road Southwest
Atlanta, Georgia 30331
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Atlanta, GA
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Costa Mesa, California 92626
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Costa Mesa, CA
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1 Elizabeth Place
Dayton, Ohio 45417
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Dayton, OH
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Decatur, Georgia 30030
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Decatur, GA
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Houston, Texas 77058
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Houston, TX
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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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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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Little Rock, Arkansas 72211
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Little Rock, AR
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New York, New York 10032
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New York, NY
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Orem, Utah 84058
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Orem, UT
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Richmond, Virginia 23298
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Richmond, VA
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Salt Lake City, Utah 84124
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Salt Lake City, UT
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San Diego, California 92103
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San Diego, CA
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