- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02237677
CB1 Receptor PET Imaging Reveals Gender Differences in PTSD
Cannabinoid-1 (CB1) Receptor Positron Emission Tomography (PET) Imaging Reveals Gender Differences in Posttraumatic Stress Disorder (PTSD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Post-traumatic stress disorder (PTSD)
|
Positron emission tomography (PET) imaging
|
Healthy Controls (HC)
|
Positron emission tomography (PET) imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume of distribution (VT) of cerebral CB1 receptor expression in PTSD and controls within a fear circuit of brain regions that regulate stress-related behaviors using the CB1 radioligand carbon - 11 (11C) [11C]OMAR and PET.
Time Frame: Two months
|
To examine group differences in cerebral CB1 receptor expression in PTSD and controls within a fear circuit of cortical and subcortical brain regions that regulate stress-related behaviors using the CB1 radioligand [11C]OMAR and PET. Hypothesis: PTSD patients will show greater [11C]OMAR VT (i.e. CB1 binding) values than both control groups, trauma-exposed and non-trauma exposed control subjects who will not be different. |
Two months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Marmar, MD, NYU School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-02787
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-traumatic Stress Disorder (PTSD)
-
Tel-Aviv Sourasky Medical CenterBeth Israel Deaconess Medical Center; Tel Aviv UniversityUnknownPost-traumatic Stress Disorder (PTSD)Israel
-
Dokuz Eylul UniversityNot yet recruitingPost-Traumatic Stress Disorder (PTSD)
-
The University of Texas at ArlingtonUniversity of Texas at AustinTerminatedPost-traumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentNot yet recruitingPost-Traumatic Stress Disorder (PTSD)United States
-
Nepalese Psychological AssociationUnknownPost-traumatic Stress Disorder (PTSD)Nepal
-
NYU Langone HealthCompleted
-
Otsuka Pharmaceutical Development & Commercialization...Iqvia Pty LtdTerminatedPost-traumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentNot yet recruitingPost-traumatic Stress Disorder (PTSD) | Self-directed ViolenceUnited States
-
Insamlingsstiftelsen Wonsa, World of No Sexual...Karolinska InstitutetCompleted
-
University of KonstanzUniversity of Stellenbosch; University of Cape TownCompletedAggressive Behavior | Post-traumatic Stress Disorder (PTSD)South Africa
Clinical Trials on Positron emission tomography (PET) imaging
-
Jagiellonian UniversityMedical University of WarsawCompletedNeurodegenerative Diseases | Brain Neoplasms | Neuroendocrine TumorsPoland
-
Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
University of WashingtonNational Cancer Institute (NCI)CompletedAdult Solid NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnOropharyngeal Squamous Cell Carcinoma | HPV Positive Oropharyngeal Squamous Cell Carcinoma
-
Stanford UniversityRecruiting
-
University of Texas Southwestern Medical CenterWithdrawn
-
Chinese PLA General HospitalUnknown
-
The Hospital for Sick ChildrenCompleted
-
Ohio State University Comprehensive Cancer CenterCompletedCigarette Smoking-Related CarcinomaUnited States
-
Stanford UniversityNational Cancer Institute (NCI)CompletedPancreatic Carcinoma | Healthy SubjectUnited States