- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00890643
Effect of Prazosin on Neurophysiology and Cognition in Post-Traumatic Stress Disorder (PTSD)
September 20, 2013 updated by: US Department of Veterans Affairs
Effect of Prazosin on Neurophysiologic Responses and Cognitive Performance in PTSD
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- VA Puget Sound Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Persons with PTSD
|
prazosin 1-20 mg/day in divided doses
Other Names:
|
Placebo Comparator: Arm 2
Persons with PTSD
|
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Responses to acoustic startle and prepulse inhibition of acoustic startle
Time Frame: baseline, week 2, week 8
|
baseline, week 2, week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate variability
Time Frame: baseline, week 2, week 8
|
baseline, week 2, week 8
|
Pennsylvania Computerized Neurocognitive Battery (CNB)
Time Frame: baseline, week 8
|
baseline, week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dorcas J. Dobie, MD, VA Puget Sound Health Care System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
April 28, 2009
First Submitted That Met QC Criteria
April 29, 2009
First Posted (Estimate)
April 30, 2009
Study Record Updates
Last Update Posted (Estimate)
September 23, 2013
Last Update Submitted That Met QC Criteria
September 20, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Prazosin
Other Study ID Numbers
- MHBA-018-08S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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