Overview

Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)

Status:
Withdrawn
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Michael Debakey Veterans Affairs Medical Center
Michael E. DeBakey VA Medical Center
Collaborators:
Acorda Therapeutics
Biotie Therapies Inc.
Lori Davis, MD Tuscaloosa VA Medical Center
Ralph H. Johnson VA Medical Center
Tuscaloosa Veterans Affairs Medical Center
Criteria
Inclusion Criteria:

1. Signed informed consent

2. Patient understands the risks and benefits and agrees to visit frequency and
procedures

3. Male or female

4. Any race or ethnic origin

5. Served in conflict zones at least one time between 1990 -2008 [includes Operation
Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc]

6. Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military

7. DSM-IV Diagnosis of Post-Traumatic Stress Disorder (PTSD)

8. No substance use disorders (except for nicotine and caffeine) in the previous 2 months

9. Free of psychotropic medication for 2 weeks prior to randomization (a low dose
sedative hypnotic is allowed for severe insomnia if used sparingly)

10. Physical and laboratory panel are within normal limits or not clinically significant

11. Women of childbearing potential must be using medically-approved methods of birth
control

12. 18 to 65 years of age

Exclusion Criteria:

1. Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders

2. Actively considering plans of suicide or homicide

3. 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

4. Unstable general medical conditions or a contraindication to the use of nepicastat

5. Intolerable side effects or allergic reaction to nepicastat

6. Women planning to become pregnant or breastfeed during the study