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Sponsors and Collaborators: |
Synosia Therapeutics, Inc. Lori Davis, MD Tuscaloosa VA Medical Center Mark Hamner, MD Ralph H. Johnson VA Medical Center |
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Information provided by: | Synosia Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00641511 |
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.
Condition | Intervention | Phase |
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Post Traumatic Stress Disorder (PTSD) |
Drug: SYN117 (nepicastat) Drug: Placebo comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pharmacogenetic Clinical Trial of Nepicastat for PTSD |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
SYN 117 120 mg/day
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Drug: SYN117 (nepicastat)
120 mg per day
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2: Placebo Comparator |
Drug: Placebo comparator
once per day placebo capsules
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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
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Grace Wu | 713-791-1414 | ggwu@bcm.tmc.edu |
Contact: David Graham, MD | 713-794-8601 | dpgraham@bcm.tmc.edu |
United States, Alabama | |
Tuscaloosa VAMC | Recruiting |
Tuscaloosa, Alabama, United States, 35404 | |
Principal Investigator: Lori Davis, MD | |
United States, South Carolina | |
Ralph H. Johnson VA Medical Center | Recruiting |
Charleston, South Carolina, United States, 29401 | |
Principal Investigator: Mark Hamner, MD | |
United States, Texas | |
Michael E. Debakey VAMC | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Thomas Kosten, MD |
Study Chair: | Thomas Kosten, MD | Baylor College of Medicine, and DeBakey VAMC |
Study Director: | Lori Davis, MD | Tuscaloosa VAMC |
Principal Investigator: | Mark Hamner, MD | Ralph H Johnson VAMC |
Responsible Party: | Jay H Waggoner Chair and Professor of Psychiatry and Neuroscience ( Thomas Kosten, MD ) |
Study ID Numbers: | H22601, Inv117-Kosten-CL01 |
Study First Received: | March 18, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00641511 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PTSD |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease Anxiety Disorders |
Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |