Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

Completed · Not applicable · Has a placebo group

Conditions studied: Non PTSD, PTSD

In brief

The overarching objectives of this study are: 1) To investigate the neurobiology of posttraumatic stress disorder (PTSD) during Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM) sleep relative to wakefulness; 2) To identify the neurobiological underpinnings of sleep treatment response to prazosin or placebo during wakefulness, REM sleep, and NREM sleep in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) ( veterans with PTSD; and 3) To explore pre-treatment brain activity patterns during wakefulness, REM sleep, and NREM sleep that predict sleep treatment response. We will also explore the stability of the Positron Emission Tomography (PET) signal by comparing pre- and post-placebo changes in brain glucose metabolism in non-responders. For non-PTSD veterans, the stability of the PET signal will be evaluated in a subsample of 6 veterans without PTSD who will repeat the PET imaging procedures 8 weeks after the initial PET series. The overarching hypothesis is that PTSD is characterized by neurobiological alterations in the amygdala, medial prefrontal cortex (mPFC), and brain centers involved in the regulation of NREM and REM sleep, and that these neurobiological changes are normalized with effective sleep treatment.

Key facts

Study ID

NCT01637584

Run by

University of Pittsburgh

People needed

40

Starts

2010-04-01

Expected to finish

2012-11-01

Last updated by the study team

2017-05-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• OIF/OEF veteran
• Between the ages of 18 and 50 years old
• Not taking medications known to affect sleep or wake function for 2 weeks
• Additional selection criteria for PTSD subjects are:
• Trauma occurred three months or more before study entry
• Meeting diagnostic criteria for current PTSD according to the Clinician Administered PTSD Scale (CAPS)
• Participants will remain in ongoing counseling services
• Additional selection criterion for non-PTSD healthy subjects:
• Not meet DSM-IV diagnostic criteria for current PTSD
• Have a total score < 13 on the Beck Depression Inventory
• Participants who are active-duty military personnel will be required to obtain permission from their commander to participate in this study.

You may not qualify if…

• Current diagnosis of untreated, severe depression as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual- IV Edition (DSM-IV), non-patient version
• Beck Depression Inventory > 30
• History of psychotic or bipolar disorder
• Current history (within 3 months) of substance or alcohol abuse
• Significant or unstable acute or chronic medical conditions
• Other current sleep disorders
• Presence of implanted devices or metal in body such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
• Fear of closed spaces
• Previous radiation exposure (past year) that exceeds recommended safety limits
• Pregnancy or breast feeding
• Resting blood pressure < 90/60 at the screening physical examination
• Heart rate > 100 beats/minutes
• Current use of a beta-blocker
• Use of an alpha-1 antagonist agent in the previous 3 weeks
• Refusal to follow the safety measures in the case of use of a phosphodiesterase 5 inhibitor (Cialis, Viagra, Levitra)
• Unexpected, untreated, or serious EKG findings

Where it is running

• Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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