Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108420
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-04-14
Brief Title:
Prazosin Treatment for Combat Trauma PTSD Post-Traumatic Stress Disorder Nightmares and Sleep Disturbance
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Prazosin Treatment for Combat Trauma PTSD Nightmares and Sleep Disturbance
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether prazosin will reduce the incidence of nightmares sleep disturbance and overall symptoms in combat trauma-exposed individuals with PTSD
Detailed Description:
The combat stress-related nightmares and sleep disturbance that often follow exposure to military combat are distressing and frequently persistent symptoms that impair quality of life and both occupational and social eg family function One of the most frequently reported and most troubling symptoms of PTSD is trauma-content nightmares These nighttime symptoms have been notoriously resistant to treatment with psychotropic medications such as anxiolytics the SSRIs and sedating antihistamines such as cyproheptadine The SSRIs sertraline Zoloft and paroxetine Paxil are the only drugs FDA approved for PTSD This approval was based on modest overall PTSD improvement compared to placebo in large multicenter trials that enrolled almost exclusively noncombat trauma subjects Placebo-controlled SSRI trials for PTSD in combat veterans have been negative or equivocal
Neurobiologic data suggest that combat stress-related nightmares and sleep disturbance in PTSD are related to enhanced central nervous system CNS adrenergic activity particularly at night Prazosin is a CNS-active non-sedating alpha-1 antagonist that has long been generically available for the treatment of hypertension and benign prostatic hypertrophy We recently demonstrated in Vietnam combat veterans with chronic PTSD that prazosin is robustly effective for previously treatment refractory combat trauma related nightmares sleep disturbance and overall PTSD severity and functional impairment
The goal of this study is to evaluate the efficacy and tolerability of prazosin compared to placebo for combat stress-related nightmares sleep disturbance and overall function in combat-trauma exposed persons with PTSD
Primary outcome measures will be Clinical Global Impression of Change Recurrent Distressing Dreams and Difficulty Falling and Staying Asleep items of the CAPS total CAPS exclusive of the dreams and sleep items and the Pittsburgh Sleep Quality Index Depression and quality of life also will be assessed
Neurobiologic data suggest that combat stress-related nightmares and sleep disturbance in PTSD are related to enhanced central nervous system CNS adrenergic activity particularly at night Prazosin is a CNS-active non-sedating alpha-1 antagonist that has long been generically available for the treatment of hypertension and benign prostatic hypertrophy We recently demonstrated in Vietnam combat veterans with chronic PTSD that prazosin is robustly effective for previously treatment refractory combat trauma related nightmares sleep disturbance and overall PTSD severity and functional impairment
The goal of this study is to evaluate the efficacy and tolerability of prazosin compared to placebo for combat stress-related nightmares sleep disturbance and overall function in combat-trauma exposed persons with PTSD
Primary outcome measures will be Clinical Global Impression of Change Recurrent Distressing Dreams and Difficulty Falling and Staying Asleep items of the CAPS total CAPS exclusive of the dreams and sleep items and the Pittsburgh Sleep Quality Index Depression and quality of life also will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None