Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder

June 12, 2018 updated by: Seattle Institute for Biomedical and Clinical Research

Prazosin for Noncombat Trauma PTSD

This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals taking selective serotonin reuptake inhibitors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. People with PTSD have persistent frightening thoughts and memories of their past ordeal and often feel emotionally numb, especially with people to whom they were once close. PTSD was first recognized in male combat veterans. Today, however, the majority of people who have PTSD are young women who have experienced non combat-related trauma, such as sexual or physical assault or a life-threatening illness or accident. The disorder can be short-lived, but PTSD can also become chronic, with long lasting symptoms that are often treatment-resistant, possibly causing severe functional disability. Frequent trauma-related nightmares and other debilitating sleep disruptions are examples of chronic PTSD symptoms for which an effective treatment has not been developed. Sertraline and paroxetine, both selective serotonin reuptake inhibitors (SSRIs), are the only drugs approved by the FDA for treating PTSD. Neither of them, however, has been effective in reducing PTSD-related sleep disruption. Studies have shown that the drug prazosin has been effective in reducing distressing trauma-related nightmares in older male combat veterans. This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals already being treated with SSRIs.

Participants in this double-blind study will first undergo 12 weeks of treatment with psychotherapy and a standard SSRI. After 12 weeks, participants will be randomly assigned to receive either prazosin or placebo in addition to psychotherapy and standard SSRI treatment for a total of 8 weeks. Study visits will occur weekly for the first 12 weeks, and then at Weeks 1, 2, 4, 6, and 8 during the 8-week phase. Additionally, follow-up visits will be held 4 and 18 weeks post-intervention. PTSD symptoms, disorder severity, and frequency of sleep disturbances will be assessed.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of PTSD, as derived from the Clinician-Administered PTSD Scale (CAPS)
  • Stabilized on any necessary medications for at least 4 weeks prior to study entry
  • Score of greater than 4 on the CAPS Recurrent Distressing Dreams item (maximum score of 8)
  • Score of greater than 4 on the CAPS Difficulty Falling or Staying Asleep item (maximum score of 8)
  • Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

  • Any acute or significant chronic medical illness
  • Any unstable medical condition
  • Unstable angina, recent heart attack, history of congestive heart failure, pre-existing hypotension (systolic blood pressure less than 110 mm Hg), or orthostatic hypotension
  • Insulin-dependent diabetes
  • Chronic kidney or liver failure
  • Pancreatitis or gout
  • Meniere's disease, benign positional vertigo, or narcolepsy
  • Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist
  • Currently taking another alpha-1 antagonist agent
  • Pregnant
  • DSM-IV diagnosis of cognitive disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic disorder
  • Current delirium
  • Active substance dependence disorder within 3 months of study entry
  • Current substance use other than alcohol (no more than 2 drinks per day)
  • Severe psychiatric instability or situational life crises, including evidence of suicidal or homicidal ideation
  • Currently taking any other psychotropic medication (e.g., antidepressants, benzodiazepines, anti-convulsants, anti-psychotics, sedating antihistamines, sedatives/hypnotics (exclusionary medications will be discontinued and participants will undergo a 2-week washout period before baseline assessments)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive treatment with prazosin plus psychotherapy
Drug: Prazosin
Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.
Other Names:
  • Minipress
Behavioral: Psychotherapy
All participants will undergo psychotherapy during medication treatment period.
Placebo Comparator: 2
Participants will receive treatment with placebo plus psychotherapy
Behavioral: Psychotherapy
All participants will undergo psychotherapy during medication treatment period.
Drug: Placebo
Placebo capsules are taken orally twice per day at 10 am and bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Change
Time Frame: Baseline to Week 8
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 Clinical Global Impression of Change is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from Baseline to Week 8.
Baseline to Week 8
Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS
Time Frame: Baseline to Week 8
Item B-2 "recurrent distressing dreams of the event" is a single item from teh Clinician Administered PTSD Scale (CAPS). The rating consists of two parts: Frequency plus Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. The total minimum score = zero. The total maximum score = 8. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 8.
Baseline to Week 8
Change in Sleep Assessed by the Pittsburgh Sleep Quality Index
Time Frame: Baseline to Week 8
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 8.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Institute for Biomedical and Clinical Research

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Murray A. Raskind, MD, University of Washington/Department of Veterans Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH069867 (U.S. NIH Grant/Contract)
  • DATR AD-TS (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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