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NCT00659230 · ClinicalTrials.gov registry record · Phase 2
Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF Veterans
A Phase 2 study, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00659230 is a Phase 2 study that has completed, run by Tuscaloosa Research & Education Advancement Corporation. The registered enrollment target is 100 participants.
The verdict
NCT00659230, a Phase 2 study, has completed, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study proposes a multi-site, randomized, double-blind, placebo-controlled clinical trial of the dopamine-ß-hydroxylase (DBH) inhibitor, nepicastat, for the treatment of posttraumatic stress disorder (PTSD) in outpatients who have previously served in a combat zone during Operation Iraqi Freedom and Operation Enduring Freedom (OIF/OEF)or other Southwest conditions since 19800. A DBH inhibitor's mechanism of action is to decrease neuronal noradrenaline (NA) release by inhibiting DBH conversion of dopamine (DA) to NA. Animal models of PTSD and human studies have found a substantial increase in NA activity for these animal models and for PTSD in humans. Furthermore, recent clinical studies have improved PTSD hyper-arousal symptoms by reducing the NA over-activity using agents like NA post-synaptic antagonists. Key support for the proposed study is based on a similar improvement in PTSD symptoms after treatment with the DBH inhibitor, disulfiram. In the experience of the clinical investigators, the most common chief complaint of the OIF/OEF veterans with PTSD is hyperarousal (DSM-IV criterion D symptom cluster). These symptoms significantly interfere with social, occupational, and interpersonal function. Standard treatments with antidepressants are not fully effective in treating the symptoms of PTSD in veterans; thus, new treatments are needed. An intervention, such as nepicastat, aimed at reducing hyperarousal, as well as other PTSD symptoms, would have significant impact of restoring overall function and quality of life in OIF/OEF veterans with PTSD. Since hyperarousal symptoms responded relatively quickly to medications of this type, our study in 120 outpatient veterans with PTSD will compare nepicastat 120 mg/day vs. placebo in a 6-week double-blind, randomized clinical trial (RCT). The veterans will be followed for an additional 8 weeks after the RCT, during which, those who have a priori defined positive clinical response to the study medication, nepicastat
Interventions
- DRUG Placebo
- DRUG Nepicastat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-07-01 |
| Est. Completion | 2012-08-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00659230
The ClinicalTrials.gov registry entry for NCT00659230 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tuscaloosa Research & Education Advancement Corporation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00659230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00659230 about?
NCT00659230 is a clinical study titled "Nepicastat for Posttraumatic Stress Disorder (PTSD) in OIF/OEF Veterans". This study proposes a multi-site, randomized, double-blind, placebo-controlled clinical trial of the dopamine-ß-hydroxylase (DBH) inhibitor, nepicastat, for the treatment of posttraumatic stress disorder (PTSD) in outpatients who have previously served in a combat zone during Operation Iraqi Freedom...
What is the current status of trial NCT00659230?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2009-07-01. Estimated completion is 2012-08-30.
What interventions are being tested in trial NCT00659230?
The interventions under investigation include: Placebo (DRUG), Nepicastat (DRUG).
Who is sponsoring clinical trial NCT00659230?
This trial is sponsored by Tuscaloosa Research & Education Advancement Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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