Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)

Seattle Institute for Biomedical and Clinical Research

Status: Completed

Conditions: Sleep Disorders; Combat Disorders; Stress Disorders, Post-Traumatic

Treatments: Drug: prazosin hydrochloride; Drug: placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00990106

1P20AA017839-01 (U.S. NIH Grant/Contract)

PT074250

Details and patient eligibility

About

The purpose of this study is to determine whether prazosin will:

• reduce the incidence of nightmares and sleep disturbance
• increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.

Full description

This is a 15-week randomized parallel design, double-blind, placebo-controlled augmentation trial of prazosin to evaluate the efficacy and tolerability of prazosin augmentation in the treatment of PTSD trauma-related nightmares, sleep disturbance, global function and sense of well-being, and other clinical features and comorbidities of PTSD. Participants will be 210 OIF/OEF soldiers and veterans who have suffered war zone trauma. Participants will be randomized 1:1 to prazosin or placebo and all previous psychotropic medications and/or psychotherapy will be maintained constant. Randomization will be stratified by site and use of an antidepressant.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age >18 years;
• Clear evidence of exposure to one or more war zone trauma events sufficient to satisfy DSM-IV criterion A1 for diagnosis of PTSD;
• DSM-IV diagnosis of PTSD derived from the CAPS; CAPS total score >50;
• CAPS Recurrent Distressing Dreams item score >5 (of maximum score of 8);
• 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 during the study.

Exclusion Criteria

• Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive disorder; substance dependence disorder within 3 months or any current substance dependence; current cocaine or stimulant abuse; severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.
• Medical - acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 2 patient groups, including a placebo group

prazosin hydrochloride

Active Comparator group

Description:

prazosin Pfizer Minipress oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose.

Treatment:

Drug: prazosin hydrochloride

placebo

Placebo Comparator group

Description:

placebo oral capsules Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose.

Treatment:

Drug: placebo