Suspended

Nepicastat for Hyper-arousal in PTSD in Combat Veterans

What is being tested

SYN117 (nepicastat)

+ Placebo comparator

Drug

Who is being recruted

Trauma and Stressor Related Disorders+1

+ Mental Disorders

+ Stress Disorders, Post-Traumatic

From 18 to 65 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: June 2008

See protocol details

Summary

Principal SponsorMichael E. DeBakey VA Medical Center

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2008

Actual date on which the first participant was enrolled.

This clinical trial focuses on treating Post Traumatic Stress Disorder (PTSD), specifically in veterans who have served in conflict zones at least once between 1990 and 2008. The main goal is to evaluate the effectiveness of a drug called nepicastat in managing hyper-arousal, a common symptom of PTSD. The study also aims to see if nepicastat can induce PTSD remission, improve other PTSD symptoms, and enhance the quality of life and overall functioning of the participants. The importance of this study lies in its potential to define a better approach to treating PTSD and improving the lives of affected veterans and active military service members. The study lasts for 6 weeks. Participants will receive either nepicastat or a placebo. The primary outcome measured is the change from the start of the study in the hyperarousal scores, as assessed by a tool called CAPS(D). This will help determine if nepicastat is more effective than a placebo in managing this symptom. The study also aims to evaluate the tolerability and side effects of nepicastat in the treatment of PTSD. The results from this pilot study will help in developing new treatment strategies for future larger studies.

Official TitlePharmacogenetic Clinical Trial of Nepicastat for PTSD

NCT00641511

Principal SponsorMichael E. DeBakey VA Medical Center

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersMental DisordersStress Disorders, Post-TraumaticStress Disorders, Traumatic

Criteria

12 inclusion criteria required to participate

Signed informed consent

Patient understands the risks and benefits and agrees to visit frequency and procedures

Male or female

Any race or ethnic origin

Show More Criteria

6 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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 II

Placebo

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Tuscaloosa VAMC

Tuscaloosa, United StatesOpen Tuscaloosa VAMC in Google Maps

Suspended

Ralph H. Johnson VA Medical Center

Charleston, United States

Suspended

Michael E. Debakey VAMC

Houston, United States

Suspended3 Study Centers