A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Completed · Phase 2 · Has a placebo group
Conditions studied: Depressive Disorder, Depression, Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorder, Pregnancy Complications, Postpartum Blues, PPD, Postpartum Disorder
In brief
A clinical study to evaluate safety, tolerability and efficacy of oral administration of ganaxolone in women with postpartum depression
Key facts
- Study ID
- NCT03460756
- Run by
- Marinus Pharmaceuticals
- People needed
- 84
- Starts
- 2017-12-28
- Expected to finish
- 2019-07-05
- Last updated by the study team
- 2023-08-18
Who can join
Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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