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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Trial Summary
Trial Overview
Inclusion Criteria

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
Marinus Research Site
New York, New York 10032
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New York, NY
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Marinus Research Site
501 Fairburn Road Southwest
Atlanta, Georgia 30331
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Atlanta, GA
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Marinus Research Site
Costa Mesa, California 92626
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Costa Mesa, CA
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Marinus Research Site
1 Elizabeth Place
Dayton, Ohio 45417
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Dayton, OH
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Marinus Research Site
Decatur, Georgia 30030
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Decatur, GA
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Marinus Research Site
Houston, Texas 77058
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Houston, TX
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Marinus Research Site
Irving, Texas 75062
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Irving, TX
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Marinus Research Site
Jacksonville, Florida 32216
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Jacksonville, FL
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Marinus Research Site
Leawood, Kansas 66206
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Leawood, KS
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Marinus Research Site
Lemon Grove, California 91945
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Lemon Grove, CA
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Marinus Research Site
Little Rock, Arkansas 72211
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Little Rock, AR
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Marinus Research Site
Orem, Utah 84058
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Orem, UT
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Marinus Research Site
Overland Park, Kansas 66211
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Overland Park, KS
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Marinus Research Site
Richmond, Virginia 23298
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Richmond, VA
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Marinus Research Site
Salt Lake City, Utah 84124
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Salt Lake City, UT
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Marinus Research Site
San Diego, California 92103
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San Diego, CA
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