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

Primary Purpose

Posttraumatic Stress Disorder

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

prazosin hydrochloride

placebo

About this trial

This is an interventional basic science trial for Posttraumatic Stress Disorder focused on measuring Stress disorders, post-traumatic, Combat Disorders, prazosin, cognition, neurophysiology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Persons with PTSD

Outcomes

Primary Outcome Measures

Responses to acoustic startle and prepulse inhibition of acoustic startle

Secondary Outcome Measures

Heart rate variability

Pennsylvania Computerized Neurocognitive Battery (CNB)

Full Information

NCT ID

NCT00890643

First Posted

April 28, 2009

Last Updated

September 20, 2013

Sponsor

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00890643

Brief Title

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

Official Title

Effect of Prazosin on Neurophysiologic Responses and Cognitive Performance in PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Primary investigator left VA employment

Study Start Date

December 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

Keywords

Stress disorders, post-traumatic, Combat Disorders, prazosin, cognition, neurophysiology

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Persons with PTSD

Arm Title

Arm 2

Arm Type

Placebo Comparator

Arm Description

Persons with PTSD

Intervention Type

Drug

Intervention Name(s)

prazosin hydrochloride

Other Intervention Name(s)

Minipress

Intervention Description

prazosin 1-20 mg/day in divided doses

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Responses to acoustic startle and prepulse inhibition of acoustic startle

Time Frame

baseline, week 2, week 8

Secondary Outcome Measure Information:

Title

Heart rate variability

Time Frame

baseline, week 2, week 8

Title

Pennsylvania Computerized Neurocognitive Battery (CNB)

Time Frame

baseline, week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorcas J. Dobie, MD

Organizational Affiliation

VA Puget Sound Health Care System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Puget Sound Health Care System

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

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

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