Ganaxolone in Posttraumatic Stress Disorder (PTSD)
Completed · Phase 2 · Has a placebo group
Conditions studied: PTSD
In brief
This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.
Key facts
- Study ID
- NCT01339689
- Run by
- Marinus Pharmaceuticals
- People needed
- 112
- Starts
- 2011-04-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2022-12-29
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
Where it is running
- VA San Diego Healthcare System/ University of California, San Diego — San Diego, California, United States
- Washington DC VA Medical Center/ Uniformed Services University of the Health Services — Washington D.C., District of Columbia, United States
- VA Boston Healthcare Services/ Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
- Manchester VA Medical Center/ Dartmouth College — Manchester, New Hampshire, United States
- Durham VA Medical Center /Duke University Medical Center — Durham, North Carolina, United States
- Cincinnati VA Medical Center/ University of Cincinnati — Cincinnati, Ohio, United States
- Charleston VA Medica Center/ Medical University of South Carolina — Charleston, South Carolina, United States
- White River Junction VA Medical Center/ Dartmouth College — White River Junction, Vermont, United States
Full record on ClinicalTrials.gov
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