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Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
This study has been completed.

First Received on March 18, 2008.   Last Updated on June 8, 2011   History of Changes
Sponsor: Michael Debakey Veterans Affairs Medical Center
Collaborators: Lori Davis, MD Tuscaloosa VA Medical Center
Mark Hamner, MD Ralph H. Johnson VA Medical Center
Biotie Therapies Inc.
Information provided by: Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00641511
  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 II

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:

Genetics Home Reference related topics: Help Me Understand Genetics
MedlinePlus related topics: Post-Traumatic Stress Disorder
Drug Information available for: Nepicastat
U.S. FDA Resources

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:

  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
  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
Mark Hamner, MD 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 February 09, 2012



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