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

NCT ID: NCT00641511

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-11-30

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

SYN117 (nepicastat)

Intervention Type: DRUG

120 mg per day

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.

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

once per day placebo capsules

Interventions

SYN117 (nepicastat)

120 mg per day

Intervention Type: DRUG

Placebo comparator

once per day placebo capsules

Intervention Type: DRUG

Other Intervention Names

nepicastat

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tuscaloosa Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

Ralph H. Johnson VA Medical Center

FED

Sponsor Role: collaborator

Acorda Therapeutics

INDUSTRY

Sponsor Role: collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Thomas Kosten, MD

, Waggoner Chair and Professor of Psychiatry, Neuroscience, Pharmacology, Immunology & Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Kosten, MD

Role: STUDY_CHAIR

Baylor College of Medicine, and DeBakey VAMC

Lori Davis, MD

Role: STUDY_DIRECTOR

Tuscaloosa VAMC

Mark Hamner, MD

Role: PRINCIPAL_INVESTIGATOR

Ralph H Johnson VAMC

David P. Graham, MD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center

Locations

Tuscaloosa VAMC

Tuscaloosa, Alabama, United States

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States

Michael E. Debakey VAMC

Houston, Texas, United States

Countries

United States

Other Identifiers

Inv117-Kosten-CL01

Identifier Type: -

Identifier Source: secondary_id

H22601

Identifier Type: -

Identifier Source: org_study_id