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Stress Disorders, Post-Traumatic | A Pilot Study to Assess the Effects of Doxazosin on Polysomnography in PTSD

Stress Disorders, Post-Traumatic research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Age 18-69 2. Current full or partial syndromal PTSD of at least 3 months duration as indexed by the CAPS (Clinician-administered PTSD scale) score >30 3. CAPS recurrent distressing dreams item of >/= 5 Exclusion Criteria: 1. alcohol and or drug abuse/dependence in the last 3 months 2. lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder 3. exposure to trauma within the last 3 months 4. prominent suicidal or homicidal ideation 5. sleep apnea diagnosis or positive screen for sleep apnea by Type III device. 6. neurologic disorder or systemic illness affecting CNS function 7. history of brain trauma or head injury with loss of consciousness greater than 10 minutes 8. 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 9. pregnancy, breastfeeding and/or refusal to use effective birth control 10. previous serious adverse reaction to an alpha-1-antagonist (such as priapism, hepatitis, angioedema, or intraoperative floppy iris syndrome) 11. current use of trazodone, hypnotics/benzodiazepines, mirtazapine, atypical antipsychotics, beta-adrenergic blockers, alpha-2-agonists, and current prazosin or other alpha-1-antagonists 12. 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Stress Disorders, Post-Traumatic

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Doxazosin XLSubjects will participate in a 2 week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Doxazosin XLSubjects will participate in a 2 week flexible-dose titration of doxazosin XL based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.

Study Status

Completed

Start Date: October 2013

Completed Date: June 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in mean total sleep time and wake-time after sleep onset as measured by polysomnography and actigraphy

Secondary Outcome: Change in mean scores on the CAPS, CAPS sleep and distressing dreams items, PCL, BDI, ISI, PSQI, PSQI-A and QOLI

Study sponsors, principal investigator, and references

Principal Investigator: Anne Richards, MD, MPH

Lead Sponsor: San Francisco Veterans Affairs Medical Center

Collaborator: United States Department of Defense

More information:https://clinicaltrials.gov/show/NCT01959022

De Jong J, Wauben P, Huijbrechts I, Oolders H, Haffmans J. Doxazosin treatment for posttraumatic stress disorder. J Clin Psychopharmacol. 2010 Feb;30(1):84-5. doi: 10.1097/JCP.0b013e3181c827ae.

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