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Withdrawn

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:
  • Minipress
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

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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