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Pharmacogenetic Clinical Trial of Nepicastat for PTSD
Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo.
The primary treatment objective is to assess the global efficacy of nepicastat in the treatment of hyper-arousal in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo. The secondary treatment objectives are to assess the ability of nepicastat to induce PTSD remission; treat PTSD and other PTSD symptom clusters and improve quality of life and overall functioning. A medical safety objective is to assess the tolerability and side effects of nepicastat in the treatment of PTSD in veterans who served in conflict zones at least one time between 1990 -2008 \[includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc . This is a 6-week study with the long-term objective is to define the best approach to treating PTSD and enhancing the quality of life in patients. Results from this pilot study will assist clinicians in treating active military service members or veterans with PTSD by developing new treatment algorithms for future larger studies.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Tuscaloosa VAMC
Tuscaloosa, Alabama, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States
Michael E. Debakey VAMC
Houston, Texas, United States
Start Date
June 1, 2008
Primary Completion Date
September 1, 2009
Completion Date
November 1, 2009
Last Updated
August 21, 2019
SYN117 (nepicastat)
DRUG
Placebo comparator
DRUG
Lead Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
NCT06580444
NCT04073862
Data Source & Attribution
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