Examination of Glutamate and mGluR5 in Psychiatric Disorders
1 other identifier
interventional
180
1 country
1
Brief Summary
This research study is designed to look at the involvement of the glutamate system in depression. Each subject will undergo a screening appointment to determine study eligibility. Thereafter, the study will take 2 or 3 visits depending on schedule availability and will consist of one MRI scan, and PET scan. Subjects will also participate in cognitive testing. Depending on camera time, staff availability and subject schedule, total study participation may last 1-2 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Feb 2012
Longer than P75 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2012
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2022
CompletedDecember 30, 2025
December 1, 2025
9.9 years
March 17, 2016
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of glutamate availability (mGluR5) in psychiatric disorders confirmed by MRI and PET data.
Through study completion date, an average of 4 years.
Study Arms (3)
Cognitive Testing
OTHERCognitive assessments
Magnetic Resonance Imaging
ACTIVE COMPARATORAll subjects will have one MRI with a possibility of one functional MRI (fmri).
Positron Emission Tomography
ACTIVE COMPARATORAll subjects will have PET scan using FPEB or ABP688.
Interventions
Anatomical MRIs will be performed on a Siemens 3T Trio at Yale. MR acquisition will be a Sag 3D magnetization-prepared rapid gradient-echo (MPRAGE) sequence with 3.34 ms echo time, 2,500 ms repetition time, 1,000 ms inversion time, 7 degree flip angle, and 180 Hz/pixel bandwidth. The image dimensions will be 256 x 256 x 176 and pixel size 0.98 x 0.98 x 1.0 mm. Resting state MRIs will also be obtained as follows: We will be doing 2 six minute scans with subjects in the scanner, eyes open, fixating a cross. TR = 3 secs 45 slices x 3 mm slice thickness = 13.5 cm. In plane resolution = 3 x 3 mm, slice acquisition order = ascending.
High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or HR+ will be used to image subjects. Vital signs (blood pressure, pulse, respiration) will be obtained before and after radiotracer administration. An antecubital venous catheter will be used for IV administration of the radiotracer and for venous blood sampling. A radial artery catheter will be inserted by an experienced physician before the PET scan. At the beginning of each scan, the subject's head will be immobilized and a 6 minute transmission scan using an orbiting 137Cs (HRRT) or 68GE (HR+) point-source is obtained and used for attenuation correction. PET scans will be acquired using bolus or bolus plus constant infusion administration of FPEB or ABP688.
Eligibility Criteria
You may qualify if:
- Subjects will be between the ages of 18-70 years old
- English speaking
- No other DSM-5 diagnosis present, besides required as below
- Clinical diagnosis of a current depressive episode
- Medication-free for at least 2 weeks or medicated with a permissible medication
- Clinical diagnosis of current PTSD as per DSM-5
- Medication free for at least 2 weeks or medicated with a permissible medication
- No current, or history of, any DSM-5 diagnosis
You may not qualify if:
- Have a current or past significant medical, neurological or metabolic disorder or head injury that lead to significant long term decline in cognitive abilities as seen by decline in grades or work performance
- Have significant medical illness such that would contraindicate study participation based on above criteria and PI/MD history review
- Have active, significant suicidal ideation
- Have implanted metallic devices or any MR contraindications
- Are women who are pregnant or breastfeeding
- Met DSM-5 criteria for mild substance use disorder (except nicotine and marijuana) within the past 6 months or met DSM-5 criteria for moderate to severe substance use disorder (except nicotine and marijuana) within the past year
- Have history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year
- Have given a blood donation within eight weeks of the start of the study
- Have history of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- VA Office of Research and Developmentcollaborator
Study Sites (1)
PET Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irina Esterlis, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2016
First Posted
April 5, 2016
Study Start
February 21, 2012
Primary Completion
January 13, 2022
Study Completion
January 13, 2022
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share