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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02237703
Enrollment
17
Registered
2014-09-11
Start date
2012-03-31
Completion date
2016-08-31
Last updated
2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Disorder (PTSD), Trauma

Keywords

Post-traumatic Stress Disorder (PTSD), Positron emission tomography (PET), Neuroimaging, Kappa opioid receptor (KOR)

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.

Interventions

Positron emission tomography (PET) imaging

Sponsors

Yale University
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

for patients with PTSD: 1. age 18-55 years old 2. currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50.

Exclusion criteria

for patients with PTSD: 1. any primary Axis I disorder other than PTSD (e.g. psychosis) 2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders 3. a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence 4. current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study) 5. current breast feeding 6. use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests 7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study 8. general MRI

Design outcomes

Primary

MeasureTime frameDescription
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 PETTwo monthsTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026