Prazosin in the pharmacological treatment of sleep disturbances in post traumatic stress disorder, a placebo-controlled study using polysomnography

Phase 4

Completed

Conditions: posttraumtic stress disorder
psychotrauma
10040998
10002861

Registration Number: NL-OMON33617

Lead Sponsor: Militaire Geestelijke Gezondheidszorg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Age between 18 - 65
Veterans, active military personnel, refugees, or civilians with psychotrauma
Subjects have to meet DSM-IV criteria for PTSD, as measured by SCID, with a CAPS score of > 50
PSQI scores of > 5

Exclusion Criteria

Substance or alcohol abuse/ dependence within the past six months
Major systemic or neurological diseases
Orthostatic hypotension before treatment
History of micturition syncope
History of allergic reaction to prazosin
Use of psychotropic medication with apha 1 antagonizing properties
Use of antihypertensive agents
Start psychotherapy in the 6 weeks proceeding the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) A decrease in number of awakenings after treatment, as measured with PSG.<br /><br>2) Subjective sleep quality using self reported questionnaires (sleep calendar,<br /><br>Pittsburgh Sleep Quality Index).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Changes of other PSG parameters after treatment (wake after sleep onset<br /><br>(WASO), sleep latency (SL), and total sleep time (TST), percentage rapid eye<br /><br>movement (REM) sleep, percentage non REM (NREM) 2, percentage NREM 3+ 4,<br /><br>delta-activity during NREM 3 + 4, mean heart rate during each sleep stage):<br /><br>2) Correlation between improvement on subjective reports and the change in<br /><br>number of awakenings.</p><br>