Orvepitant (GW823296) in Adult Post Traumatic Stress Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Post-Traumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT01000493

Run by

GlaxoSmithKline

People needed

132

Starts

2009-11-02

Expected to finish

2010-06-28

Last updated by the study team

2017-09-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Park Ridge, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Glen Burnie, Maryland, United States
• GSK Investigational Site — Weymouth, Massachusetts, United States
• GSK Investigational Site — Willingboro, New Jersey, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Garfield Heights, Ohio, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Memphis, Tennessee, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Salt Lake City, Utah, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Brown Deer, Wisconsin, United States

Full record on ClinicalTrials.gov

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