Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) - NCT00990106-98108 (Clinical Trial 368320)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy368320.aspx
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| City: |
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Seattle |
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State:
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WA |
| Zip Code: |
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98108 |
| Conditions: |
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Stress Disorders, Post-Traumatic - Combat Disorders - Sleep Disorders |
| Purpose: |
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The purpose of this study is to determine whether prazosin will:
- reduce the incidence of nightmares and sleep disturbance
- increase functioning and sense of well being in combat-trauma exposed OIF/OEF veterans.
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| Study summary: |
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This is a 15-week randomized parallel design, double-blind, placebo-controlled augmentation
trial of prazosin to evaluate the efficacy and tolerability of prazosin augmentation in the
treatment of PTSD trauma-related nightmares, sleep disturbance, global function and sense of
well-being, and other clinical features and comorbidities of PTSD. Participants will be 210
OIF/OEF soldiers and veterans who have suffered war zone trauma. Participants will be
randomized 1:1 to prazosin or placebo and all previous psychotropic medications and/or
psychotherapy will be maintained constant. Randomization will be stratified by site and use
of an antidepressant. |
| Criteria: |
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Inclusion Criteria
- Age >18 years;
- Clear evidence of exposure to one or more war zone trauma events sufficient to
satisfy DSM-IV criterion A1 for diagnosis of PTSD;
- DSM-IV diagnosis of PTSD derived from the CAPS; CAPS total score >50;
- CAPS Recurrent Distressing Dreams item score >5 (of maximum score of 8);
- stable dose of non-exclusionary medications and psychotherapeutic treatment for at
least 4 weeks prior to randomization;
- good general medical health.
- Female participants must agree to use a reliable form of birth control during the
study.
Exclusion Criteria
- Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia,
schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive
disorder; substance dependence disorder within 3 months or any current substance
dependence; current cocaine or stimulant abuse; severe psychiatric instability or
severe situational life crises, including evidence of being actively suicidal or
homicidal, or any behavior which poses an immediate danger to patient or others.
- Medical - acute or unstable chronic medical illness, including unstable angina,
recent myocardial infarction (within 6 months), congestive heart failure, preexisting
hypotension or orthostatic hypotension, chronic renal or hepatic failure,
pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed
sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1
antagonist. |
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| Study is available at: |
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VA Puget Sound Health Care System
Seattle, WA 98108
United States
Primary Contact:
Kasse Rupp, BS
Email: kasse.rupp@va.gov
Phone: 206-277-1037
Secondary Contact:
Hollie Holmes, BA
Email: Hollie.Holmes@va.gov
Phone: 206-277-6207 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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