Orvepitant (GW823296) in Adult Post Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: orvepitant; Placebo
Intervention description: Neurokinin-1 (NK-1) antagonist; Inactive placebo to match orvepitant 60 mg dosage form
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: efficacy; double-blind; Clinician Administered PTSD Scale; placebo; Sleep; safety; CAPS; neurokinin-1 antagonist; orvepitant; PTSD; randomized; Post traumatic stress disorder; Phase II

Summary:

      This is a 12-week, randomized, multicenter, double-blind, placebo controlled, fixed-dose
      parallel group study to assess the efficacy and safety of orvepitant (60 mg/day) versus
      placebo in subjects with a diagnosis of noncombat-related Posttraumatic Stress Disorder
      (PTSD), whose symptoms are considered moderate or severe.

      Following an initial screening visit, subjects fulfilling the study inclusion and exclusion
      criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory
      and ECG assessments and to confirm eligibility for inclusion into the study. This screening
      phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the
      screening period, eligible subjects will be randomized at the baseline visit to receive
      either orvepitant 60mg/day or placebo (1:1 ratio). Those subjects randomized to receive
      placebo will receive study medication identical in appearance to that received by subjects
      assigned to receive orvepitant.

      Efficacy will be assessed using the Clinician Administered PTSD Scale (CAPS) as the primary
      efficacy measure. Key secondary efficacy endpoints will be based on the Davidson Trauma Scale
      (DTS), the Short PTSD Rating Interview (SPRINT), the Clinical Global Impression- Global
      Improvement and Severity of Illness Scales (CGI-I and CGI-S, respectively), the Hamilton
      Depression Rating Scale (HAM-D), the Cognitive and Physical Functioning Questionnaire (CPFQ)
      and the Pittsburgh Sleep Quality Index (PSQI).

      Safety will be assessed by monitoring for adverse events (side effects) and through periodic
      laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart
      rate, temperature) and heart function measurements (electrocardiograms, or ECGs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-64 years, inclusive.

          -  A primary diagnosis of noncombat-related Post traumatic Stress Disorder (PTSD)

          -  Subjects with symptom severity considered to be at least moderate to severe.

        Exclusion Criteria:

          -  Subjects whose symptoms are better accounted for by a diagnosis other than Post
             traumatic Stress Disorder (PTSD), subjects diagnosed with dementia; subjects diagnosed
             with a current/recent eating disorder such as anorexia nervosa or bulimia; subjects
             with a diagnosed history of schizophrenia, schizoaffective disorder, or Bipolar
             Disorder.

          -  Subjects who have a history of failing to respond to adequate treatment for PTSD with
             an antidepressant/anti-anxiety drug, i..e, failure to improve following administration
             of at least two other antidepressants/anti-anxiety drugs, each given for at least 4
             weeks.