Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep (REM-P)

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University of Pittsburgh

Status

Completed

Conditions

Post-Traumatic Stress Disorder

Treatments

Other: PET scan - REM Sleep
Other: PET scan - waking
Other: Sleep data recording

Study type

Observational

Funder types

Other

Identifiers

NCT00871650
MH083035-01

Details and patient eligibility

About

The overarching aim of this Exploratory/Developmental Research Grant Award (R21) is to explore the neurobiological correlates of PTSD during REM sleep by using state-of-the science positron emission tomography (PET) sleep imaging. This study will allow us to gain insight into the differences in sleep and waking brain mechanisms between veterans with PTSD and those without PTSD.

Enrollment

24 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

  • Male OIF/OEF returnees between the ages of 18 and 45 years old
  • Combat Exposure Scale score > 17
  • Not taking medications known to affect sleep or wake function for at least 2 weeks (6 weeks for fluoxetine).
  • No history of trauma before age 18

Specific Inclusion Criteria for Subjects with PTSD:

  • Meet diagnostic criteria for current PTSD according to the CAPS-1
  • CAPS-1 score is less than 80

Specific Inclusion Criteria for Subjects without PTSD:

  • Total CAPS-1 scores < 17
  • Does not meet criteria for PTSD

Exclusion Criteria:

  • Trauma occurred less than 3 months prior to study entry
  • CES score < 17
  • Taking medications known to affect sleep and / or brain glucose metabolism
  • Current diagnosis of depression as determined by the SCID or BDI score > 13
  • History of psychotic or bipolar disorder
  • Current history (within 3 months) of substance or alcohol abuse as determined by the SCID
  • Positive alcohol blood test at screening or during the PET protocol
  • Significant or unstable acute or chronic medical conditions
  • Other current sleep disorders, such as insufficient sleep syndrome, delayed sleep phase syndrome, narcolepsy, restless legs syndrome, periodic leg movement disorder, obstructive sleep apnea, and current night shift work, suspected during the structured interview. Individuals who are found to have a apnea-hypopnea index (AHI) > 10 or an index of periodic leg movements with arousal > 15 will be excluded.
  • Presence of implanted devices such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
  • Fear of closed spaces
  • Previous radiation. Due to the risk of radiation exposure, we will exclude subjects who have had PET scans or other radiotracer exposure in the previous year.
  • History of open head injury.

Trial design

24 participants in 2 patient groups

Combat Veterans with PTSD
Description:
Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with Combat Exposure Scale score > 17, who are not on medication and do not have trauma history before age 18.
Treatment:
Other: Sleep data recording
Other: PET scan - waking
Other: PET scan - REM Sleep
Combat Veterans without PTSD
Description:
Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with combat experience, who are not suffering from PTSD, and who are not on medication.
Treatment:
Other: Sleep data recording
Other: PET scan - waking
Other: PET scan - REM Sleep

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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