Effect of Prazosin on Neurophysiology and Cognition in Post-Traumatic Stress Disorder (PTSD) - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00890643

Purpose

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.

Condition	Intervention
Posttraumatic Stress Disorder	Drug: prazosin hydrochloride Drug: placebo

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Prazosin Prazosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Effect of Prazosin on Neurophysiologic Responses and Cognitive Performance in PTSD

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Responses to acoustic startle and prepulse inhibition of acoustic startle [ Time Frame: baseline, week 2, week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Heart rate variability [ Time Frame: baseline, week 2, week 8 ] [ Designated as safety issue: No ]
Pennsylvania Computerized Neurocognitive Battery (CNB) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	June 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Persons with PTSD	Drug: prazosin hydrochloride prazosin 1-20 mg/day in divided doses
2: Placebo Comparator Persons with PTSD	Drug: placebo placebo

Detailed Description:

Converging lines of evidence suggest that central noradrenergic 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 non-prescribed 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890643

Contacts

Contact: Dorcas J Dobie, MD	(206) 764-2007	dorcas.dobie@va.gov
Contact: Denise Pritzl, MSW	(206) 277-4731	denise.pritzl@va.gov

Locations

United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Dorcas J. Dobie, MD

VA Puget Sound Health Care System

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Dobie, Dorcas - Principal Investigator )
Study ID Numbers:	MHBA-018-08S
Study First Received:	April 28, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00890643 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Stress disorders, post-traumatic
Combat Disorders
prazosin
cognition
neurophysiology

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Stress
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Stress Disorders, Traumatic

Combat Disorders
Anxiety Disorders
Mental Disorders
Prazosin
Stress Disorders, Post-Traumatic
Adrenergic Antagonists

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Stress
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Pharmacologic Actions
Stress Disorders, Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders
Prazosin
Therapeutic Uses
Stress Disorders, Post-Traumatic
Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 07, 2009