Back to resultsFAAH Availability in Psychiatric Disorders: A PET Study
Primary Purpose
Post Traumatic Stress Disorder, Alcohol Use Disorder, Psychosis
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[11C]MK-3168
Sponsored by
About this trial
This is an interventional other trial for Post Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18 and 65 years, inclusive
- Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs
PTSD Inclusion Criteria:
- Diagnosis of Post-Traumatic Stress Disorder
AUD Inclusion Criteria:
- Diagnosis of Alcohol Use Disorder
Psychosis Inclusion Criteria:
- Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder
Exclusion Criteria:
- Presence of ferromagnetic metal in the body or heart pacemaker
- Women with a positive pregnancy test or women who are lactating
Sites / Locations
- Connecticut Mental Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[11C]MK-3168 PET Scan
Arm Description
Outcomes
Primary Outcome Measures
Total distribution of [11C]MK-3168 in the brain
FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04404712
Brief Title
FAAH Availability in Psychiatric Disorders: A PET Study
Official Title
FAAH Availability in Psychiatric Disorders: A PET Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Ligand was not effective.
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.
Detailed Description
This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy control individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Alcohol Use Disorder, Psychosis
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[11C]MK-3168 PET Scan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[11C]MK-3168
Intervention Description
One PET scan involving administration of PET ligand [11C]MK-3168
Primary Outcome Measure Information:
Title
Total distribution of [11C]MK-3168 in the brain
Description
FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution
Time Frame
PET scan day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18 and 65 years, inclusive
Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs
PTSD Inclusion Criteria:
Diagnosis of Post-Traumatic Stress Disorder
AUD Inclusion Criteria:
Diagnosis of Alcohol Use Disorder
Psychosis Inclusion Criteria:
Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder
Exclusion Criteria:
Presence of ferromagnetic metal in the body or heart pacemaker
Women with a positive pregnancy test or women who are lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohini Ranganathan, MBBS
Organizational Affiliation
Neuroscience Research Training Program (NRTP); Office of Cooperative Research; Psychiatry; Schizophrenia Research Clinic; Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FAAH Availability in Psychiatric Disorders: A PET Study
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