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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000030-39-NL
Enrollment
30
Registered
2007-08-09
Start date
2008-12-16
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

posttraumatic stress disorder (PTSD)

Interventions

Trade Name: prazosine ratiopharm Product Name: prazosin Pharmaceutical Form: Capsule* INN or Proposed INN: prazosin Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo

Sponsors

Ministery of Defense, Military Mental Health - Research Centre
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: - Efficacy of prazosin in PTSD related sleep disturbances, as measured with polysomnography and self administered sleep questoinnaires;Secondary Objective: - Correlation between subjctive and objective sleep quality. ;Primary end point(s): - Number of awakenings according to polysommnography - Scores of PSQI—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026