Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder

NCT00183430 | Terminated Results DMC

• 2 other identifiers: R01MH069867DATR AD-TS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorder; Sleep Initiation and Maintenance Disorders

Keywords

Prazosin; Sleep Disorders

Outcome Measures

Primary Outcomes (3)

• Clinical Global Impression of Change

  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

  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

  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

Study Arms (2)

1

EXPERIMENTAL

Participants will receive treatment with prazosin plus psychotherapy

Drug: Prazosin; Behavioral: Psychotherapy

2

PLACEBO COMPARATOR

Participants will receive treatment with placebo plus psychotherapy

Drug: Placebo; Behavioral: Psychotherapy

Interventions

Prazosin DRUG

Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.

Also known as: Minipress

1

Placebo DRUG

Placebo capsules are taken orally twice per day at 10 am and bedtime.

2

Psychotherapy BEHAVIORAL

All participants will undergo psychotherapy during medication treatment period.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (6)

• 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. doi: 10.1176/appi.ajp.160.2.371.

  PMID: 12562588 BACKGROUND

• 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. doi: 10.4088/jcp.v63n0705.

  PMID: 12143911 BACKGROUND

• 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. doi: 10.4088/jcp.v61n0208.

  PMID: 10732660 BACKGROUND

• 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. doi: 10.1177/0891988703256050.

  PMID: 12967060 BACKGROUND

• 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. 2008 Mar 15;63(6):629-32. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.

  PMID: 17868655 BACKGROUND

• 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. doi: 10.1016/j.biopsych.2006.06.032. Epub 2006 Oct 25.

  PMID: 17069768 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

Prazosin; Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Murray A. Raskind, MD
• Organization: VA Puget Sound HCS

Murray.Raskind@va.gov

206-277-3797

Study Officials

• Murray A. Raskind, MD

  University of Washington/Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2003
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2010
• Last Updated: June 14, 2018
• Results First Posted: November 27, 2012

Record last verified: 2018-06

Locations

US (1)