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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

A Placebo-Controlled Augmentation Trial of Prazosin for PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990106
• Other study ID #: PT074250
• Secondary ID: 1P20AA017839-01
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2018
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Combat Disorders
• Disease
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• prazosin hydrochloride
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
placebo

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	National Institute on Alcohol Abuse and Alcoholism (NIAAA), United States Department of Defense, VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Raskind MA, Peterson K, Williams T, Hoff DJ, Hart K, Holmes H, Homas D, Hill J, Daniels C, Calohan J, Millard SP, Rohde K, O'Connell J, Pritzl D, Feiszli K, Petrie EC, Gross C, Mayer CL, Freed MC, Engel C, Peskind ER. A trial of prazosin for combat trauma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item	Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15.	Baseline to Week 15
Primary	Change in Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.	Baseline to Week 15
Primary	Clinical Global Impression of Change (CGIC)	The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.	Change from Baseline to Week 15