Prazosin vs. Paroxetine in Combat Stress Symptoms in OIF/OEF Returnees

NCT00261729 | Completed DMC

• 2 other identifiers: MHBA-025-05S0026
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat stress-related nightmares, sleep disturbance and overall function in recently combat-exposed returnees from OIF and OEF. To evaluate the effects of the SSRI paroxetine on behavioral symptoms and overall function in this population.

Conditions

Sleep Disorders; Stress Disorders, Post-Traumatic

Keywords

Paroxetine; Prazosin; Sleep Disorders; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• CAPS recurrent distressing dreams item

  baseline, 6 weeks, 12 weeks

Secondary Outcomes (5)

• Pittsburgh Sleep Quality Index

  baseline, 6 weeks, 12 weeks

• Clinical Global Impression of Change

  baseline, 6 weeks, 12 weeks

• Total CAPS

  baseline, 6 weeks, 12 weeks

• Quality of Life Inventory

  baseline, 6 weeks, 12 weeks

• Penn Alcohol Craving Scale

  baseline, 6 weeks, 12 weeks

Study Arms (3)

1

EXPERIMENTAL

paroxetine

Drug: Paroxetine

2

PLACEBO COMPARATOR

placebo

Drug: placebo

3

EXPERIMENTAL

prazosin

Drug: Prazosin

Interventions

Paroxetine DRUG

paroxetine 20 mg

Also known as: Paxil

1

Prazosin DRUG

Prazosin

3

placebo DRUG

placebo capsules

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hazardous duty in Iraq or Afghanistan with the US Armed Forces during Operations Iraqi Freedom and Operation Enduring Freedom
• Exposure to at least a moderate level of combat (\>5 on Revised Combat Exposure Scale)
• Good general medical health
• Stable dose of non-excluded medications for at least 4 weeks prior to randomization
• \>5 on CAPS recurrent distressing dreams item
• \>5 on CAPS difficulty falling or staying asleep item

You may not qualify if:

• Acute or significant chronic medical illness, preexisting hypotension or orthostatic hypotension, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy, or any other unstable medical condition.
• Women of childbearing potential with either positive pregnancy test or refusal to use effective birth control method will be excluded.
• Lifetime schizophrenia, schizoaffective disorder, bipolar disorder, psychotic disorder or any DSM-IV cognitive disorder, current delirium, substance dependence disorder within 3 months of the study, 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.
• Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist or paroxetine or any other SSRI, no concurrent use of another alpha-1 antagonist agent, no concurrent use an antidepressant (other than trazodone prescribed for sleep).

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (6)

• 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

• 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

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Sleep Wake Disorders; Stress Disorders, Post-Traumatic

Interventions

Paroxetine; Prazosin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Elaine Peskind, MD

  VA Puget Sound Health Care System, Seattle

  PRINCIPAL INVESTIGATOR

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: FED

Study Record Dates

• First Submitted: December 1, 2005
• First Posted: December 5, 2005
• Study Start: July 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2009
• Last Updated: December 3, 2009

Record last verified: 2009-12

Locations

US (1)