Ganaxolone in Posttraumatic Stress Disorder (PTSD)
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Ganaxolone; Placebo
Intervention description: 200-600 mg bid, capsules, up to 12 weeks; capsules, bid, up to 12 weeks
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: PTSD; Posttraumatic Stress Disorder; pharmacotherapy; ganaxolone

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.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined
             by Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV) for at least 6
             months

          -  Must be in general good health-confirmed by medical history, physical examination, and
             screening laboratory results

          -  Negative urine drug screen for drugs of abuse

          -  Negative urine pregnancy test for females of childbearing potential

          -  Sexually active participants are required to use a medically acceptable form of birth
             control

        Key Exclusion Criteria

          -  Clinically unstable medical disease; progressive CNS disorder/disease; history of
             seizures (except childhood febrile seizure); moderate or severe traumatic brain injury
             (TBI)

          -  Females who are pregnant or currently breast feeding

          -  Current or past psychotic disorder, bipolar Type I disorder, or dementia

          -  Participants with recent drug abuse or dependency (excluding nicotine and caffeine)

          -  Participants unwilling to comply with the required alcohol prohibition during the
             trial

          -  Current suicidal or homicidal ideation necessitating intervention, and those with a
             history of suicide attempt in the past 10 years

          -  Participants with pending litigation related to the traumatic event

          -  Participants who are unwilling to withhold grapefruit or grapefruit juice for the
             duration of the study

          -  Participants receiving psychotherapy without a stable paradigm for at least 3 months

          -  Non-English speaking participants.