Effect of Prazosin on Neurophysiology and Cognition in Post-Traumatic Stress Disorder (PTSD) - NCT00890643-98109 (Clinical Trial 289413)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy289413.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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98109 |
| Conditions: |
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Posttraumatic Stress Disorder |
| Purpose: |
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In this study, the investigators are looking at how PTSD affects things such as memory,
attention, reaction to sounds, eye movements, and heart rate. The investigators are also
studying whether a medication called prazosin has an effect on these things.
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| Study summary: |
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Converging lines of evidence suggest that central nor adrenergic function is perturbed in
PTSD. Placebo-controlled trials demonstrate that the centrally acting alpha-1 antagonist
prazosin is clinically effective for several core symptoms of PTSD in combat veterans.
However, no detailed assessment of the impact of prazosin on human neurophysiology and
cognition have been conducted. Our hypotheses are based on studies that demonstrate (1) the
importance of central adrenergic receptors in regulating fundamental neurophysiologic and
cognitive functions, (2) the alteration of these functions in PTSD, and (3) the efficacy of
prazosin in improving the clinical symptoms of PTSD. The primary objective of this study is
to measure the subtle neurocognitive and neurophysiologic effects on prazosin in combat
veterans with PTSD. |
| Criteria: |
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Inclusion Criteria:
- Exposure to one or more life-threatening war zone trauma events;
- DSM-IV diagnosis of PTSD derived from the Clinician-Administered PTSD Scale (CAPS),
CAPS total score greater than or equal to 50;
- CAPS recurrent distressing dreams item score greater than or equal to 5 (of a maximum
score of 8), with a frequency rating greater than or equal to 2 (of 4);
- 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 throughout
study.
Exclusion Criteria:
- Acute or unstable chronic medical illness;
- diagnosis of current schizophrenia, schizoaffective disorder, psychotic disorder not
otherwise specified, bipolar disorder, delirium, or cognitive disorder;
- severe psychiatric instability or severe situational life crises;
- substance dependence disorder currently or in past 3 months;
- current cocaine or stimulant abuse or evidence of acute intoxication on alcohol or
nonprescribed medication;
- allergy or previous adverse reaction to prazosin or other alpha-1 adrenergic
antagonists;
- serious head injury with loss of consciousness of greater than 30 minutes;
- current diagnosis of seizure disorder;
- current use of prazosin or other alpha-1 adrenergic antagonists;
- current use of atypical antipsychotic medication;
- stimulants or alternative medications with stimulant properties (e.g. ephedra),
certain exposure therapies must be completed at least 4 weeks before baseline;
- certain medications (trazodone, erectile disfunction medications) are not allowed or
are restricted during the study;
- women must not be pregnant or nursing during the study. |
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| Study is available at: |
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VA Puget Sound Health Care System
Seattle, WA 98109
United States
Primary Contact:
Allen Radant, MD
Email: allen.radant@va.gov
Phone: 206-277-1761
Secondary Contact:
Allen Radant, MD
Email: allen.radant@va.gov
Phone: (206) 277-1761 |
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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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March 16, 2010 |
Modifications to
this listing: |
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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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