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

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Withdrawn

CT.gov ID

NCT00890643

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Drug: prazosin hydrochloride Drug: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Basic Science

Official Title:

Effect of Prazosin on Neurophysiologic Responses and Cognitive Performance in PTSD

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Persons with PTSD	Drug: prazosin hydrochloride prazosin 1-20 mg/day in divided doses Other Names: Minipress
Placebo Comparator: Arm 2 Persons with PTSD	Drug: placebo placebo

Arm

Intervention/Treatment

Experimental: Arm 1

Persons with PTSD

Drug: prazosin hydrochloride

prazosin 1-20 mg/day in divided doses

Other Names:

Minipress

Placebo Comparator: Arm 2

Persons with PTSD

Drug: placebo

placebo

Outcome Measures

Primary Outcome Measures

Responses to acoustic startle and prepulse inhibition of acoustic startle [baseline, week 2, week 8]

Secondary Outcome Measures

Heart rate variability [baseline, week 2, week 8]
Pennsylvania Computerized Neurocognitive Battery (CNB) [baseline, week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.