N/A
Completed N=67
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
Stress Disorders, Post-Traumatic · Combat Disorders · Sleep Disorders, Intrinsic
Source: ClinicalTrials.gov NCT00990106 ↗
Enrolled (actual)
67
Serious AEs
3.0%
Results posted
Sep 2014
Primary outcomePrimary: Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item — 3.1; 1.2 Scores on a Scale
Summary
The purpose of this study is to determine whether prazosin will:
* reduce the incidence of nightmares and sleep disturbance
* increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item |
3.1; 1.2 | — |
| PRIMARY Change in Pittsburgh Sleep Quality Index (PSQI) |
5.6; 2.8 | — |
| PRIMARY Clinical Global Impression of Change (CGIC) |
64; 27 | — |
Eligibility Criteria
Inclusion Criteria
- Age >18 years;
- Clear evidence of exposure to one or more war zone trauma events sufficient to satisfy DSM-IV criterion A1 for diagnosis of PTSD;
- DSM-IV diagnosis of PTSD derived from the CAPS; CAPS total score >50;
- CAPS Recurrent Distressing Dreams item score >5 (of maximum score of 8);
- stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;
- good general medical health.
- Female participants must agree to use a reliable form of birth control during the study.
Exclusion Criteria
- Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive disorder; substance dependence disorder within 3 months or any current substance dependence; current cocaine or stimulant abuse; severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.
- Medical - acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.
Data sourced from ClinicalTrials.gov (NCT00990106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.