Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance

NCT00108420 | Completed Phase 4

• 1 other identifier: CLIN-018-02F
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether prazosin will reduce the incidence of nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with PTSD.

Conditions

Stress Disorder, Post-Traumatic

Keywords

Prazosin; Stress Disorders, Post-traumatic

Outcome Measures

Primary Outcomes (6)

• Clinical Global Impression of Change

• Recurrent Distressing Dreams and Difficulty Falling and Staying Asleep items of the CAPS

• Total CAPS (exclusive of the dreams and sleep items)

• The Pittsburgh Sleep Quality Index

• Depression

• Quality of life

Interventions

Prazosin DRUG

Eligibility Criteria

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

You may qualify if:

• Combat-trauma exposed persons with a diagnosis of PTSD
• No diagnosis of lifetime schizophrenia, schizoaffective disorder, bipolar disorder, psychotic disorder, or any DSM-IV cognitive disorder; current delirium, or substance dependence disorder within 3 months of the study or current substance use other than alcohol (no more than 2 drinks/day); severe psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others
• In good general medical health (no acute or significant chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension \[systolic \<110\] or orthostatic hypotension \[systolic drop \> 20 mmHg after two minutes standing or any drop with dizziness\]; insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, Meniere's disease, benign positional vertigo, narcolepsy, allergy or previous adverse reaction to prazosin or other alpha-1 antagonist, or any unstable medical condition).
• Stable dose of nonexcluded medications for concurrent stable medical conditions for at least 4 weeks prior to randomization.
• Specific criteria used to validate presence of combat stress-related nightmares and sleep disturbance will include: score \> 5 (of a maximum score of 8) on the CAPS Recurrent Distressing Dreams item. (CAPS score \>5 places subjects in the upper third of nightmare severity) or score \> 5 (of a maximum score of 8) on the CAPS Difficulty Falling or Staying Asleep item.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: April 14, 2005
• First Posted: April 15, 2005
• Study Start: October 1, 2003
• Study Completion: March 1, 2007
• Last Updated: January 21, 2009

Record last verified: 2007-05

Locations

US (1)