NCT00641511

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

Pharmacogenetic Clinical Trial of Nepicastat for PTSD

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Michael E. DeBakey VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	SYN117 (nepicastat)	120 mg per day
DRUG	Placebo comparator	once per day placebo capsules

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-09-01
• Completion: 2009-11-01
• First posted: 2008-03-24
• Last updated: 2019-08-21

Locations

3 sites across 1 country: United States