Prazosin as add-on therapy in the pharmacological treatment of sleep disturbances in post traumatic stress disorder, a placebo-controlled study using polysomnography - prazosin in the treatment of PTSD related sleep disturbances
- Conditions
- posttraumatic stress disorder (PTSD)
- Registration Number
- EUCTR2007-000030-39-NL
- Lead Sponsor
- Ministery of Defense, Military Mental Health - Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 30
-Age between 18 - 65
-Veterans or active military personnel
-History of deployment
-Subjects have to meet DSM-IV criteria for PTSD, as measured by SCID, with a CAPS score of > 50
-PSQI scores of > 10
-SSRI treatment for at least 6 weeks at stable and adequate dosage
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Substance or alcohol abuse/ dependence within the past six months
-Major systemic or neurological diseases
-Organic sleep disorders (sleep apnea syndrome, periodic limb movement disorder, narcolepsy)
-Orthostatic hypotension before treatment, defined as a fall in systolic blood pressure of more then 20mmHg, or a fall in diastolic blood pressure of more then 10 mmHg after 2 minutes standing.
-Use of psychotropic medication, other than a SSRI, or hypertensive agents.
-Chronic benzodiazepine use. Benzodiazepine use on demand has to be stopped at least two weeks before the study. A patient will only be included if no rebound insomnia has been noticed prior to the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method