Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
This study has been completed.
Sponsor:
Michael Debakey Veterans Affairs Medical Center
Collaborators:
Lori Davis, MD Tuscaloosa VA Medical Center
Ralph H. Johnson VA Medical Center
Biotie Therapies Inc.
Information provided by:
Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00641511
First received: March 18, 2008
Last updated: June 8, 2011
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Traumatic Stress Disorder (PTSD) |
Drug: SYN117 (nepicastat) Drug: Placebo comparator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pharmacogenetic Clinical Trial of Nepicastat for PTSD |
Resource links provided by NLM:
Further study details as provided by Michael Debakey Veterans Affairs Medical Center:
Primary Outcome Measures:
- Change from baseline in CAPS(D) hyperarousal scores as compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo [ Time Frame: 6 weeeks ] [ Designated as safety issue: Yes ]
- Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Clinicians global impression of Severity and Improvement [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Sheehan Disability Scale as compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
SYN 117 120 mg/day
|
Drug: SYN117 (nepicastat)
120 mg per day
Other Name: nepicastat
|
| Placebo Comparator: 2 |
Drug: Placebo comparator
once per day placebo capsules
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc]
- Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
- DSM-IV Diagnosis of Post-Traumatic Stress Disorder (PTSD)
- No substance use disorders (except for nicotine and caffeine) in the previous 2 months
- Free of psychotropic medication for 2 weeks prior to randomization (a low dose sedative hypnotic is allowed for severe insomnia if used sparingly)
- 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
- 18 to 65 years of age
Exclusion Criteria:
- 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
- Intolerable side effects or allergic reaction to nepicastat
- Women planning to become pregnant or breastfeed during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641511
Locations
| United States, Alabama | |
| Tuscaloosa VAMC | |
| Tuscaloosa, Alabama, United States, 35404 | |
| United States, South Carolina | |
| Ralph H. Johnson VA Medical Center | |
| Charleston, South Carolina, United States, 29401 | |
| United States, Texas | |
| Michael E. Debakey VAMC | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Michael Debakey Veterans Affairs Medical Center
Lori Davis, MD Tuscaloosa VA Medical Center
Ralph H. Johnson VA Medical Center
Biotie Therapies Inc.
Investigators
| Study Chair: | Thomas Kosten, MD | Baylor College of Medicine, and DeBakey VAMC |
| Study Director: | Lori Davis, MD | Tuscaloosa VAMC |
| Principal Investigator: | Mark Hamner, MD | Ralph H Johnson VAMC |
More Information
No publications provided
| Responsible Party: | Thomas Kosten, MD, Jay H Waggoner Chair and Professor of Psychiatry and Neuroscience |
| ClinicalTrials.gov Identifier: | NCT00641511 History of Changes |
| Other Study ID Numbers: | H22601, Inv117-Kosten-CL01 |
| Study First Received: | March 18, 2008 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Michael Debakey Veterans Affairs Medical Center:
|
PTSD |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013