NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

WithdrawnPhase 2

Sponsor: Michael E. DeBakey VA Medical Center

Conditions: Post Traumatic Stress Disorder (PTSD)

Interventions: SYN117 (nepicastat), Placebo comparator

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (3)

Tuscaloosa, Alabama, United States
Charleston, South Carolina, United States
Houston, Texas, United States