Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD) - Full Text View

Sponsors and Collaborators:	Synosia Therapeutics, Inc. Lori Davis, MD Tuscaloosa VA Medical Center Mark Hamner, MD Ralph H. Johnson VA Medical Center
Information provided by:	Synosia Therapeutics, Inc.
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

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Nepicastat

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pharmacogenetic Clinical Trial of Nepicastat for PTSD

Further study details as provided by Synosia Therapeutics, Inc.:

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
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental SYN 117 120 mg/day	Drug: SYN117 (nepicastat) 120 mg per day
2: Placebo Comparator	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

Contacts

Contact: Grace Wu	713-791-1414	ggwu@bcm.tmc.edu
Contact: David Graham, MD	713-794-8601	dpgraham@bcm.tmc.edu

Locations

United States, Alabama
Tuscaloosa VAMC	Recruiting
Tuscaloosa, Alabama, United States, 35404
Principal Investigator: Lori Davis, MD
United States, South Carolina
Ralph H. Johnson VA Medical Center	Recruiting
Charleston, South Carolina, United States, 29401
Principal Investigator: Mark Hamner, MD
United States, Texas
Michael E. Debakey VAMC	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Thomas Kosten, MD

Sponsors and Collaborators

Synosia Therapeutics, Inc.

Lori Davis, MD Tuscaloosa VA Medical Center

Mark Hamner, MD Ralph H. Johnson VA Medical Center

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

Responsible Party:	Jay H Waggoner Chair and Professor of Psychiatry and Neuroscience ( Thomas Kosten, MD )
Study ID Numbers:	H22601, Inv117-Kosten-CL01
Study First Received:	March 18, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00641511
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synosia Therapeutics, Inc.:

PTSD

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009