Post Traumatic Stress Disorder (PTSD)
Conditions
Keywords
PTSD
Brief 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.
Detailed description
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 -2008 \[includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc . 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.
Interventions
DRUGSYN117 (nepicastat)
120 mg per day
DRUGPlacebo comparator
once per day placebo capsules
Sponsors
Tuscaloosa Veterans Affairs Medical Center
Ralph H. Johnson VA Medical Center
Acorda Therapeutics
Michael E. DeBakey VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in CAPS(D) hyperarousal scores as compared to placebo | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo | 6 weeks |
| Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). | 6 weeks |
| Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo | 6 weeks |
| Change from baseline in Sheehan Disability Scale as compared to placebo | 6 weeks |
| Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo | 6 weeks |
| Clinicians global impression of Severity and Improvement | 6 weeks |
| Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo | 6 weeeks |
Countries
United States
Outcome results
None listed