Overview

This trial is active, not recruiting.

Conditions stress disorders, post-traumatic, combat disorders, sleep disorders
Treatments prazosin hydrochloride, placebo
Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborator Department of Defense
Start date September 2009
End date June 2013
Trial size 300 participants
Trial identifier NCT00990106, PT074250

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
prazosin hydrochloride prazosin
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. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.
(Placebo Comparator)
placebo sugar pill
placebo

Primary Outcomes

Measure
Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item
time frame: Baseline, Weeks 7, 11 and 15
Pittsburgh Sleep Quality Index (PSQI)
time frame: Baseline, Weeks 7, 11 and 15
Clinical Global Impression of Change (CGIC)
time frame: Weeks 7, 11 and 15

Secondary Outcomes

Measure
Clinician-Administered PTSD Scale (CAPS) Total Score
time frame: Baseline, Weeks 7, 11 and 15
CAPS symptom clusters (Reexperiencing/Intrusions, Numbing/Avoidance, and Hyperarousal)
time frame: Baseline, Weeks 7, 11 and 15
Hamilton Depression Scale (HAM-D)
time frame: Baseline, Weeks 7, 11 and 15
Patient Health Questionnaire-9 (PHQ-9)
time frame: Baseline, Weeks 7, 11 and 15
Quality Of Life Inventory (QOLI)
time frame: Baseline, Weeks 7, 11 and 15
SF-12V
time frame: Baseline, Weeks 7, 11 and 15
Penn Alcohol Craving Scale (PACS)
time frame: Baseline, Weeks 7, 11 and 15
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
time frame: Baseline, Weeks 7, 11 and 15

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Placebo-Controlled Augmentation Trial of Prazosin for PTSD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Seattle Institute for Biomedical and Clinical Research.