A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression
Completed · Phase 2 · Has a placebo group
Conditions studied: Depression, Depressive Disorder, Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorders, Puerperal Disorders, Pregnancy Complications, Postpartum, PPD
In brief
This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression
Key facts
- Study ID
- NCT03228394
- Run by
- Marinus Pharmaceuticals
- People needed
- 91
- Starts
- 2017-06-27
- Expected to finish
- 2020-05-10
- Last updated by the study team
- 2023-07-19
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Marinus Research Site — Little Rock, Arkansas, United States
- Marinus Research Site — Costa Mesa, California, United States
- Marinus Research Site — Lemon Grove, California, United States
- Marinus Research Site — San Diego, California, United States
- Marinus Research Site — Jacksonville, Florida, United States
- Marinus Research Site — Atlanta, Georgia, United States
- Marinus Research Site — Decatur, Georgia, United States
- Marinus Research Site — Leawood, Kansas, United States
- Marinus Research Site — Overland Park, Kansas, United States
- Marinus Research Site — New York, New York, United States
- Marinus Research Site — Dayton, Ohio, United States
- Marinus Research Site — Houston, Texas, United States
- Marinus Research Site — Irving, Texas, United States
- Marinus Research Site — Orem, Utah, United States
- Marinus Research Site — Salt Lake City, Utah, United States
- Marinus Research Site — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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