EUCTR2007-000030-39-NLActive, not recruitingNot Applicable
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
Ministery of Defense, Military Mental Health - Research Centre0 sites30 target enrollmentStarted: August 9, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •-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
Exclusion Criteria
- •-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.
Investigators
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