Status:
TERMINATED
CB1 Receptor PET Imaging Reveals Gender Differences in PTSD
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Yale University
Conditions:
Post-traumatic Stress Disorder (PTSD)
Eligibility:
All Genders
18-55 years
Brief Summary
The objective of the proposed translational study is to test a model, based upon basic science studies, exploring multisystem impairments in PTSD including endocannabinoid (eCB) and glucocorticoids in...
Detailed Description
The eCB - anandamide and 2-arachidonoylglycerol (2-AG) - and their attending cannabinoid (CB) receptors which are found in high densities in a fear circuitry involving the amygdala, hippocampus, the a...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patients with PTSD:
- age 18-55 years old
- currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score \> 50.
- Inclusion Criteria for healthy subjects:
- age 18-55 years old
- no personal or first-degree family history of any Axis I diagnosis.
- Exclusion criteria for Patients with PTSD:
- 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 (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
- nicotine dependence
- suicidal ideation or behavior
- general MRI exclusion criteria, i.e. pacemakers, metals in the body
- 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 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.
- Exclusion criteria for healthy subjects:
- any history or current primary Axis I disorder
- medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders
- a history of drug (including benzodiazepines \[BZD\]) dependence (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
- nicotine dependence
- suicidal ideation or behavior
- general MRI exclusion criteria, i.e. pacemakers, metals in the body
- HIV (due to possible neuropsychiatric effects)
- use of opioid medications within 2 weeks of the PET study
- having an abnormality in the 12-lead 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.
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02237677
Start Date
June 1 2012
End Date
March 1 2016
Last Update
August 17 2016
Active Locations (1)
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1
NYU School of Medicine
New York, New York, United States, 10016