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

Prazosin 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
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33617
Enrollment
50
Registered
2008-10-13
Start date
2009-01-08
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

posttraumtic stress disorder psychotrauma

Interventions

Treatment with prazosin or placebo for 8 weeks.

Sponsors

Militaire Geestelijke Gezondheidszorg
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1) A decrease in number of awakenings after treatment, as measured with PSG. 2) Subjective sleep quality using self reported questionnaires (sleep calendar, Pittsburgh Sleep Quality Index).

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)