Status:
TERMINATED
Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Post-Traumatic Stress Disorder
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals taking selective serotonin reuptake inhibitors.
Detailed Description
Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened. People with PTSD have persis...
Eligibility Criteria
Inclusion
- Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of PTSD, as derived from the Clinician-Administered PTSD Scale (CAPS)
- Stabilized on any necessary medications for at least 4 weeks prior to study entry
- Score of greater than 4 on the CAPS Recurrent Distressing Dreams item (maximum score of 8)
- Score of greater than 4 on the CAPS Difficulty Falling or Staying Asleep item (maximum score of 8)
- Agrees to use an effective form of contraception throughout the study
Exclusion
- Any acute or significant chronic medical illness
- Any unstable medical condition
- Unstable angina, recent heart attack, history of congestive heart failure, pre-existing hypotension (systolic blood pressure less than 110 mm Hg), or orthostatic hypotension
- Insulin-dependent diabetes
- Chronic kidney or liver failure
- Pancreatitis or gout
- Meniere's disease, benign positional vertigo, or narcolepsy
- Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist
- Currently taking another alpha-1 antagonist agent
- Pregnant
- DSM-IV diagnosis of cognitive disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic disorder
- Current delirium
- Active substance dependence disorder within 3 months of study entry
- Current substance use other than alcohol (no more than 2 drinks per day)
- Severe psychiatric instability or situational life crises, including evidence of suicidal or homicidal ideation
- Currently taking any other psychotropic medication (e.g., antidepressants, benzodiazepines, anti-convulsants, anti-psychotics, sedating antihistamines, sedatives/hypnotics (exclusionary medications will be discontinued and participants will undergo a 2-week washout period before baseline assessments)
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00183430
Start Date
October 1 2003
End Date
December 1 2010
Last Update
June 14 2018
Active Locations (1)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108