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

This study has been completed.
Sponsor:
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

March 18, 2008
June 8, 2011
June 2008
September 2009   (final data collection date for primary outcome measure)
Change from baseline in CAPS(D) hyperarousal scores as compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00641511 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
Pharmacogenetic Clinical Trial of Nepicastat for PTSD

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post Traumatic Stress Disorder (PTSD)
  • Drug: SYN117 (nepicastat)
    120 mg per day
    Other Name: nepicastat
  • Drug: Placebo comparator
    once per day placebo capsules
  • Experimental: 1
    SYN 117 120 mg/day
    Intervention: Drug: SYN117 (nepicastat)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00641511
H22601, Inv117-Kosten-CL01
Yes
Thomas Kosten, MD, Jay H Waggoner Chair and Professor of Psychiatry and Neuroscience
Michael Debakey Veterans Affairs Medical Center
  • Lori Davis, MD Tuscaloosa VA Medical Center
  • Ralph H. Johnson VA Medical Center
  • Biotie Therapies Inc.
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
Michael Debakey Veterans Affairs Medical Center
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP