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

NCT00890643 | Withdrawn DMC

• 1 other identifier: MHBA-018-08S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Responses to acoustic startle and prepulse inhibition of acoustic startle

  baseline, week 2, week 8

Secondary Outcomes (2)

• Heart rate variability

  baseline, week 2, week 8

• Pennsylvania Computerized Neurocognitive Battery (CNB)

  baseline, week 8

Study Arms (2)

Arm 1

EXPERIMENTAL

Persons with PTSD

Drug: prazosin hydrochloride

Arm 2

PLACEBO COMPARATOR

Persons with PTSD

Drug: placebo

Interventions

prazosin hydrochloride DRUG

prazosin 1-20 mg/day in divided doses

Also known as: Minipress

Arm 1

placebo DRUG

placebo

Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• good general medical health;
• female participants must agree to use a reliable form of birth control throughout study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dorcas J. Dobie, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 30, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

US (1)