Status:
COMPLETED
Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF Veterans
Lead Sponsor:
Tuscaloosa Research & Education Advancement Corporation
Collaborating Sponsors:
Acorda Therapeutics
Ralph H. Johnson VA Medical Center
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This study proposes a multi-site, randomized, double-blind, placebo-controlled clinical trial of the dopamine-ß-hydroxylase (DBH) inhibitor, nepicastat, for the treatment of posttraumatic stress disor...
Detailed Description
HYPOTHESES Primary Hypothesis: Compared to placebo treatment, nepicastat-treated OIF/OEF veterans with PTSD will have significantly reduced PTSD hyperarousal symptoms as defined by the Clinician Admin...
Eligibility Criteria
Inclusion
- 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 OIF/OEF or Afghanistan conflicts or other Southwest Asia conditions
- Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
- Diagnosis of PTSD (by MINI (Mini International Neuropsychiatric Interview) and CAPS-DX (Clinician Administered PTSD scale- Diagnostic Form) using Rule of Fours and total CAPS-DX score of 45)
- No substance use disorders in the previous 2 weeks and no substance dependence disorders in the past 4 weeks (except for nicotine and caffeine)
- Free of psychotropic medication for 2 weeks prior to randomization
- 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
- ≥19 to 65 years of age
Exclusion
- 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
- Women planning to become pregnant or breastfeed during the study
- Current or pending incarceration
- Terminal Illness
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00659230
Start Date
July 1 2009
End Date
August 30 2012
Last Update
October 13 2017
Active Locations (3)
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1
Tuscaloosa VAMC
Tuscaloosa, Alabama, United States, 35404
2
VA San Diego Healthcare System
San Diego, California, United States, 92161
3
James J.Peters VA Medical Center
The Bronx, New York, United States, 10468