Conditions: PTSD
Keywords: PTSD Posttraumatic Stress Disorder pharmacotherapy ganaxolone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: active arm 2: non-active

Interventions: intervention 1: Ganaxolone intervention 2: Placebo
Intervention descriptions: intervention 1: 200-600 mg bid, capsules, up to 12 weeks intervention 2: capsules, bid, up to 12 weeks

Protocol document: