Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder

This study has been terminated.
(Insufficient Enrollment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00183430
First received: September 13, 2005
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Post-Traumatic Stress Disorder
Sleep Initiation and Maintenance Disorders
Drug: Prazosin
Drug: Placebo
Behavioral: Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prazosin for Noncombat Trauma PTSD

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Clinical Global Impression of Change [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change in Sleep Assessed by the Pittsburgh Sleep Quality Index [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Total CAPS Score [ Time Frame: Measured at Weeks 4 and 8 post-treatment ] [ Designated as safety issue: No ]
  • CAPS Subscale Scores ("Reexperiencing/Intrusions", "Avoidance/Numbing", and "Hyperarousal") [ Time Frame: Measured at Weeks 4 and 8 post-treatment ] [ Designated as safety issue: No ]
  • Measures of Nightmare Frequency, Depressive Signs and Symptoms, Quality of Life, and Number of Study Days Completed [ Time Frame: Measured at Weeks 4 and 8 post-treatment ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2003
Study Completion Date: December 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Minipress
Behavioral: Psychotherapy
All participants will undergo psychotherapy during medication treatment period.
Placebo Comparator: 2
Participants will receive treatment with placebo plus psychotherapy
Drug: Placebo
Placebo capsules are taken orally twice per day at 10 am and bedtime.
Behavioral: Psychotherapy
All participants will undergo psychotherapy during medication treatment period.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183430

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
Investigators
Principal Investigator: Murray A. Raskind, MD University of Washington/Department of Veterans Affairs
  More Information

Publications:

Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT00183430     History of Changes
Other Study ID Numbers: R01 MH069867, R01MH069867, DATR AD-TS
Study First Received: September 13, 2005
Results First Received: October 22, 2012
Last Updated: November 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
Prazosin
Sleep Disorders

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Disease
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Prazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014