Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183430

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

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Sleep Disorders Wounds

Drug Information available for: Prazosin Prazosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prazosin for Noncombat Trauma PTSD

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Clinical Global Impression of Change [ Time Frame: Measured at Weeks 4 and 8 post-treatment ] [ Designated as safety issue: No ]
Recurring Distressing Dreams and Difficulty Falling and Staying Asleep items of the CAPS [ Time Frame: Measured at Weeks 4 and 8 post-treatment ] [ Designated as safety issue: No ]
Pittsburgh Sleep Quality Index [ Time Frame: Measured at Weeks 4 and 8 post-treatment ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment:	95
Study Start Date:	October 2003
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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. Behavioral: Psychotherapy All participants will undergo psychotherapy during medication treatment period.
2: Placebo Comparator 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:

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

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

Contacts

Contact: Hollie A. Holmes, BA

206-277-6207

hollie.holmes@va.gov

Locations

United States, Washington
VA Puget Sound Health Care System	Recruiting
Seattle, Washington, United States, 98108
Contact: Hollie A. Holmes, BA 206-277-6207 hollie.holmes@va.gov
Sub-Investigator: Elaine R. Peskind, MD
Sub-Investigator: Miles McFall, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Murray A. Raskind, MD

University of Washington/Department of Veterans Affairs

More Information

Publications:

Raskind MA, Peskind ER, Kanter ED, Petrie EC, Radant A, Thompson CE, Dobie DJ, Hoff D, Rein RJ, Straits-Troster K, Thomas RG, McFall MM. Reduction of nightmares and other PTSD symptoms in combat veterans by prazosin: a placebo-controlled study. Am J Psychiatry. 2003 Feb;160(2):371-3.

Raskind MA, Thompson C, Petrie EC, Dobie DJ, Rein RJ, Hoff DJ, McFall ME, Peskind ER. Prazosin reduces nightmares in combat veterans with posttraumatic stress disorder. J Clin Psychiatry. 2002 Jul;63(7):565-8.

Raskind MA, Dobie DJ, Kanter ED, Petrie EC, Thompson CE, Peskind ER. The alpha1-adrenergic antagonist prazosin ameliorates combat trauma nightmares in veterans with posttraumatic stress disorder: a report of 4 cases. J Clin Psychiatry. 2000 Feb;61(2):129-33.

Peskind ER, Bonner LT, Hoff DJ, Raskind MA. Prazosin reduces trauma-related nightmares in older men with chronic posttraumatic stress disorder. J Geriatr Psychiatry Neurol. 2003 Sep;16(3):165-71.

Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin Effects on Objective Sleep Measures and Clinical Symptoms in Civilian Trauma Posttraumatic Stress Disorder: A Placebo-Controlled Study. Biol Psychiatry. 2007 Sep 12; [Epub ahead of print]

Raskind MA, Peskind ER, Hoff DJ, Hart KL, Holmes HA, Warren D, Shofer J, O'Connell J, Taylor F, Gross C, Rohde K, McFall ME. A parallel group placebo controlled study of prazosin for trauma nightmares and sleep disturbance in combat veterans with post-traumatic stress disorder. Biol Psychiatry. 2007 Apr 15;61(8):928-34. Epub 2006 Oct 25.

Responsible Party:	University of Washington School of Medicine/VA Puget Sound Health Care System ( Murray Raskind, MD, Professor, Executive Director, Mental Health Services )
Study ID Numbers:	R01 MH69867, DATR AD-TS
Study First Received:	September 13, 2005
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00183430
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Prazosin
Sleep Disorders

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Anxiety Disorders
Prazosin
Mental Disorders
Wounds and Injuries
Dyssomnias

Stress Disorders, Post-Traumatic
Stress
Sleep Disorders
Stress Disorders, Traumatic
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on January 30, 2009