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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183430 |
This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals taking selective serotonin reuptake inhibitors.
Condition | Intervention |
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Post-Traumatic Stress Disorder Sleep Initiation and Maintenance Disorders |
Drug: Prazosin Drug: Placebo Behavioral: Psychotherapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prazosin for Noncombat Trauma PTSD |
Estimated Enrollment: | 95 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive treatment with prazosin plus psychotherapy
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Drug: Prazosin
Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Behavioral: Psychotherapy
All participants will undergo psychotherapy during medication treatment period.
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2: Placebo Comparator
Participants will receive treatment with placebo plus psychotherapy
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Drug: Placebo
Placebo capsules are taken orally twice per day at 10 am and bedtime.
Behavioral: Psychotherapy
All participants will undergo psychotherapy during medication treatment period.
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Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. People with PTSD have persistent frightening thoughts and memories of their past ordeal and often feel emotionally numb, especially with people to whom they were once close. PTSD was first recognized in male combat veterans. Today, however, the majority of people who have PTSD are young women who have experienced non combat-related trauma, such as sexual or physical assault or a life-threatening illness or accident. The disorder can be short-lived, but PTSD can also become chronic, with long lasting symptoms that are often treatment-resistant, possibly causing severe functional disability. Frequent trauma-related nightmares and other debilitating sleep disruptions are examples of chronic PTSD symptoms for which an effective treatment has not been developed. Sertraline and paroxetine, both selective serotonin reuptake inhibitors (SSRIs), are the only drugs approved by the FDA for treating PTSD. Neither of them, however, has been effective in reducing PTSD-related sleep disruption. Studies have shown that the drug prazosin has been effective in reducing distressing trauma-related nightmares in older male combat veterans. This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals already being treated with SSRIs.
Participants in this double-blind study will first undergo 12 weeks of treatment with psychotherapy and a standard SSRI. After 12 weeks, participants will be randomly assigned to receive either prazosin or placebo in addition to psychotherapy and standard SSRI treatment for a total of 8 weeks. Study visits will occur weekly for the first 12 weeks, and then at Weeks 1, 2, 4, 6, and 8 during the 8-week phase. Additionally, follow-up visits will be held 4 and 18 weeks post-intervention. PTSD symptoms, disorder severity, and frequency of sleep disturbances will be assessed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hollie A. Holmes, BA | 206-277-6207 | hollie.holmes@va.gov |
United States, Washington | |
VA Puget Sound Health Care System | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: Hollie A. Holmes, BA 206-277-6207 hollie.holmes@va.gov | |
Sub-Investigator: Elaine R. Peskind, MD | |
Sub-Investigator: Miles McFall, PhD |
Principal Investigator: | Murray A. Raskind, MD | University of Washington/Department of Veterans Affairs |
Responsible Party: | University of Washington School of Medicine/VA Puget Sound Health Care System ( Murray Raskind, MD, Professor, Executive Director, Mental Health Services ) |
Study ID Numbers: | R01 MH69867, DATR AD-TS |
Study First Received: | September 13, 2005 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00183430 |
Health Authority: | United States: Federal Government |
Prazosin Sleep Disorders |
Sleep Initiation and Maintenance Disorders Anxiety Disorders Prazosin Mental Disorders Wounds and Injuries Dyssomnias |
Stress Disorders, Post-Traumatic Stress Sleep Disorders Stress Disorders, Traumatic Sleep Disorders, Intrinsic |
Neurotransmitter Agents Disease Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Adrenergic alpha-Antagonists |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Adrenergic Antagonists |