Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Post Traumatic Stress Disorder (PTSD)
In brief
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.
Key facts
- Study ID
- NCT00641511
- Run by
- Michael E. DeBakey VA Medical Center
- People needed
- 0
- Starts
- 2008-06-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2019-08-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent
- Patient understands the risks and benefits and agrees to visit frequency and procedures
- Male or female
- Any race or ethnic origin
- Served in conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc]
- Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
- DSM-IV Diagnosis of Post-Traumatic Stress Disorder (PTSD)
- No substance use disorders (except for nicotine and caffeine) in the previous 2 months
- Free of psychotropic medication for 2 weeks prior to randomization (a low dose sedative hypnotic is allowed for severe insomnia if used sparingly)
- Physical and laboratory panel are within normal limits or not clinically significant
- Women of childbearing potential must be using medically-approved methods of birth control
- 18 to 65 years of age
You may not qualify if…
- Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders
- Actively considering plans of suicide or homicide
- Psychotic symptoms that in the investigator's opinion impair the patient's ability to give informed consent or make it unsafe for patient to be maintained without a neuroleptic
- Unstable general medical conditions or a contraindication to the use of nepicastat
- Intolerable side effects or allergic reaction to nepicastat
- Women planning to become pregnant or breastfeed during the study
Where it is running
- 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
Full record on ClinicalTrials.gov
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