Post-Traumatic Stress Disorder Clinical Trial
— REM-POfficial title:
Neurobiological Correlates of PTSD During REM Sleep (REM-P)
Verified date | January 2013 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | November 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain glucose metabolism | During waking | Yes | |
Primary | Brain glucose metabolism | During REM sleep | No |
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