A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD

Completed · Phase 4

Conditions studied: Stress Disorders, Post-Traumatic

In brief

This study will assess the effects of the medication doxazosin on sleep in men and women with PTSD. Sleep will be measured objectively at home using a portable sleep recorder and wrist actigraphy.

Key facts

Study ID

NCT01959022

Run by

San Francisco Veterans Affairs Medical Center

People needed

15

Starts

2013-10-01

Expected to finish

2016-06-01

Last updated by the study team

2016-10-20

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-69
• Current full or partial syndromal PTSD of at least 3 months duration as indexed by the CAPS (Clinician-administered PTSD scale) score >30
• CAPS recurrent distressing dreams item of >/= 5

You may not qualify if…

• alcohol and or drug abuse/dependence in the last 3 months
• lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder
• exposure to trauma within the last 3 months
• prominent suicidal or homicidal ideation
• sleep apnea diagnosis or positive screen for sleep apnea by Type III device.
• neurologic disorder or systemic illness affecting CNS function
• history of brain trauma or head injury with loss of consciousness greater than 10 minutes
• chronic or unstable medical illness including unstable angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, and pancreatitis
• pregnancy, breastfeeding and/or refusal to use effective birth control
• previous serious adverse reaction to an alpha-1-antagonist (such as priapism, hepatitis, angioedema, or intraoperative floppy iris syndrome)
• current use of trazodone, hypnotics/benzodiazepines, mirtazapine, atypical antipsychotics, beta-adrenergic blockers, alpha-2-agonists, and current prazosin or other alpha-1-antagonists
• previous non-response to prazosin for treatment of PTSD related sleep disturbance
• Participants taking SSRIs, bupropion, venlafaxine and duloxetine may be included if they have been on a stable dose for 2 months. Participants may be included if they have been stable in psychotherapy treatment for 2 months and/or if they begin no new psychotherapy while in the trial.

Where it is running

• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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