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

Post Traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Pharmacogenetic Clinical Trial of Nepicastat for PTSD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00641511
• Other study ID #: H22601
• Secondary ID: Inv117-Kosten-CL
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: August 2019
• Source: Michael Debakey Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• SYN117 (nepicastat)
120 mg per day
• Placebo comparator
once per day placebo capsules

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center	Charleston	South Carolina
United States	Michael E. Debakey VAMC	Houston	Texas
United States	Tuscaloosa VAMC	Tuscaloosa	Alabama

Sponsors (4)

Lead Sponsor	Collaborator
Michael Debakey Veterans Affairs Medical Center	Acorda Therapeutics, Ralph H. Johnson VA Medical Center, Tuscaloosa Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in CAPS(D) hyperarousal scores as compared to placebo		6 weeks
Secondary	Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo		6 weeeks
Secondary	Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo		6 weeks
Secondary	Clinicians global impression of Severity and Improvement		6 weeks
Secondary	Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).		6 weeks
Secondary	Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo		6 weeks
Secondary	Change from baseline in Sheehan Disability Scale as compared to placebo		6 weeks
Secondary	Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo		6 weeks