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

NCT01959022 | Completed Phase 4

• 1 other identifier: A-16907.5
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Posttramatic Stress Disorder; Post-traumatic Stress Disorder; PTSD; Doxazosin; Nightmares; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

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

  baseline and 8 weeks

• Change in REM sleep time and REM period duration as measured by polysomnography

  baseline and 8 weeks

Secondary Outcomes (1)

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

  baseline and 8 weeks

Study Arms (1)

Doxazosin XL

EXPERIMENTAL

Subjects 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.

Drug: Doxazosin XL

Interventions

Doxazosin XL DRUG

Subjects 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.

Also known as: Cardura XL

Doxazosin XL

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead
• United States Department of Defense: collaborator
• Northern California Institute of Research and Education: collaborator

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (2)

• 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. No abstract available.

  PMID: 20075659 BACKGROUND

• Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: a placebo-controlled study. Biol Psychiatry. 2008 Mar 15;63(6):629-32. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.

  PMID: 17868655 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Parasomnias

Interventions

Doxazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anne Richards, MD, MPH

  San Francisco Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 9, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 20, 2016

Record last verified: 2016-10

Locations

US (1)