Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)

Terminated

• Conditions: Post-traumatic Stress Disorder (PTSD); Trauma
• Interventions: Other: Positron emission tomography (PET) imaging

• Registration Number: NCT02237703
• Lead Sponsor: NYU Langone Health

Brief Summary

This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one PET study. The investigators will also carefully document trauma history, and collect behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11 (11C)\[11C\]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-11
• Primary Completion: 2015-03
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-traumatic stress disorder (PTSD)	Positron emission tomography (PET) imaging	Post-traumatic stress disorder (PTSD)
Trauma Control (TC)	Positron emission tomography (PET) imaging	Trauma Control (TC)
Healthy Control (HC)	Positron emission tomography (PET) imaging	Healthy Control (HC)

Primary Outcome Measures

Name	Time	Method
Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET	Two months	To examine group differences in cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand \[11C\]LY2795050 and PET.; Hypothesis: PTSD will show greater \[11C\]LY2795050 VT (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States