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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

June 8, 2011

Start Date ^ICMJE

June 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in CAPS(D) hyperarousal scores as compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641511 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pharmacogenetic Clinical Trial of Nepicastat for PTSD

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Post Traumatic Stress Disorder (PTSD)

Intervention ^ICMJE

Drug: SYN117 (nepicastat)
120 mg per day

Other Name: nepicastat
Drug: Placebo comparator
once per day placebo capsules

Study Arm (s)

Experimental: 1
SYN 117 120 mg/day

Intervention: Drug: SYN117 (nepicastat)
Placebo Comparator: 2
Intervention: Drug: Placebo comparator

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00641511

Other Study ID Numbers ^ICMJE

H22601, Inv117-Kosten-CL01

Has Data Monitoring Committee

Yes

Responsible Party

Thomas Kosten, MD, Jay H Waggoner Chair and Professor of Psychiatry and Neuroscience

Study Sponsor ^ICMJE

Michael Debakey Veterans Affairs Medical Center

Collaborators ^ICMJE

Lori Davis, MD Tuscaloosa VA Medical Center
Ralph H. Johnson VA Medical Center
Biotie Therapies Inc.

Investigators ^ICMJE

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

Information Provided By

Michael Debakey Veterans Affairs Medical Center

Verification Date

December 2009

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

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