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Trial record 38 of 1597 for:    veterans affairs medical center

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

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ClinicalTrials.gov Identifier: NCT00641511
Recruitment Status : Withdrawn (Houston site withdrew as a study site.)
First Posted : March 24, 2008
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Tuscaloosa Veterans Affairs Medical Center
Ralph H. Johnson VA Medical Center
Acorda Therapeutics
Information provided by (Responsible Party):
Thomas Kosten, MD, Michael Debakey Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder (PTSD) Drug: SYN117 (nepicastat) Drug: Placebo comparator Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacogenetic Clinical Trial of Nepicastat for PTSD
Study Start Date : June 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 (Medication arm - SYN117 aka Nepicastat)
Veterans will be receiving the study medication Nepicastat initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily; During the 8 weeks (weeks: 7-14) extension phase, those from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed for an additional 8 weeks. Those who have a prior defined positive clinical response to the study medication, Nepicastat, will be continued on open label Nepicastat at 120mg once daily, in order to assess further improvement and safety; those who do not have a positive clinical response during the 6 weeks RCT will be offered the addition of the standard first-line PTSD pharmacotherapy, Paroxetine. Paroxetine is an allowed concomitant medication (i.e. "rescue medication") and is not considered a research medication or subject of a research question during the 8 weeks extension phase.
Drug: SYN117 (nepicastat)
120 mg per day
Other Name: nepicastat

Placebo Comparator: 2 (Placebo arm)
During the 6 weeks ( weeks: 1-6) double- blind, randomized clinical trial (RCT) phase, the veterans who have been randomized to the placebo treatment group will be receiving placebo pills. During the 8 weeks (weeks: 7-14) extension phase, all veterans from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed by the study team for an additional 8 weeks. The veterans on the placebo during the RCT will receive the study medication at end of the study week 6, the medication will be initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily for 8 weeks until the end of the study.
Drug: Placebo comparator
once per day placebo capsules




Primary Outcome Measures :
  1. Change from baseline in CAPS(D) hyperarousal scores as compared to placebo [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo [ Time Frame: 6 weeeks ]
  2. Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo [ Time Frame: 6 weeks ]
  3. Clinicians global impression of Severity and Improvement [ Time Frame: 6 weeks ]
  4. Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). [ Time Frame: 6 weeks ]
  5. Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo [ Time Frame: 6 weeks ]
  6. Change from baseline in Sheehan Disability Scale as compared to placebo [ Time Frame: 6 weeks ]
  7. Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641511


Locations
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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
Tuscaloosa Veterans Affairs Medical Center
Ralph H. Johnson VA Medical Center
Acorda Therapeutics
Investigators
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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
Principal Investigator: David P. Graham, MD Michael E. DeBakey VA Medical Center

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Responsible Party: Thomas Kosten, MD, , Waggoner Chair and Professor of Psychiatry, Neuroscience, Pharmacology, Immunology & Pathology, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00641511     History of Changes
Other Study ID Numbers: H22601
Inv117-Kosten-CL01
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Keywords provided by Thomas Kosten, MD, Michael Debakey Veterans Affairs Medical Center:
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders