Clinical trial NCT00641511: Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
Official title: Pharmacogenetic Clinical Trial of Nepicastat for PTSD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder (PTSD)
Keywords: PTSD
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: Tuscaloosa Veterans Affairs Medical Center
name: Ralph H. Johnson VA Medical Center
name: Acorda Therapeutics
First posted: 2008-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in CAPS(D) hyperarousal scores as compared to placebo
timeFrame: 6 weeks
Secondary outcomes:
measure: Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo
timeFrame: 6 weeeks
measure: Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo
timeFrame: 6 weeks
measure: Clinicians global impression of Severity and Improvement
timeFrame: 6 weeks
measure: Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
timeFrame: 6 weeks
measure: Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo
timeFrame: 6 weeks
measure: Change from baseline in Sheehan Disability Scale as compared to placebo
timeFrame: 6 weeks
measure: Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VAMC
state: Alabama
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Houston
country: United States
facility: Michael E. Debakey VAMC
state: Texas
Study officials:
affiliation: Baylor College of Medicine, and DeBakey VAMC
name: Thomas Kosten, MD
role: STUDY_CHAIR
affiliation: Tuscaloosa VAMC
name: Lori Davis, MD
role: STUDY_DIRECTOR
affiliation: Ralph H Johnson VAMC
name: Mark Hamner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michael E. DeBakey VA Medical Center
name: David P. Graham, MD
role: PRINCIPAL_INVESTIGATOR
References: