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

NCT02237703 | Terminated DMC

• 1 other identifier: S12-01521
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder (PTSD); Trauma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Two months

Study Arms (3)

Post-traumatic stress disorder (PTSD)

Post-traumatic stress disorder (PTSD)

Other: Positron emission tomography (PET) imaging

Trauma Control (TC)

Trauma Control (TC)

Other: Positron emission tomography (PET) imaging

Healthy Control (HC)

Healthy Control (HC)

Other: Positron emission tomography (PET) imaging

Interventions

Positron emission tomography (PET) imaging OTHER

Positron emission tomography (PET) imaging

Healthy Control (HC); Post-traumatic stress disorder (PTSD); Trauma Control (TC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are between the age range of 18 to 55, are medically healthy and currently not taking any medications to treat any medical illness, have a history of post-traumatic stress disorder, or are a healthy control who has or has not been exposed to trauma.

You may qualify if:

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

You may not qualify if:

• any primary Axis I disorder other than PTSD (e.g. psychosis)
• medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
• 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
• current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)
• current breast feeding
• 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
• 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
• Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects);
• use of opioid medications within 2 weeks of the PET study
• having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participation in the study
• seriously claustrophobic
• blood donation within 8 weeks prior to the study.
• age 18-55 years old
• no personal or first-degree family history of any Axis I diagnosis.
• any history or current primary Axis I disorder

Sponsors & Collaborators

• NYU Langone Health: lead
• Yale University: collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Charles Marmar, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)