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Glutamate Imaging and Cognitive Testing for Depression
N/A
Recruiting
Led By Irina Esterlis, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medication-free for at least 2 weeks or medicated with a permissible medication for acute depressed subjects
Clinical diagnosis of a current depressive episode for acute depressed subjects
Must not have
Have history of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
Have active, significant suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trialstudies how glutamate affects depression and requires MRI/PET scans, cognitive testing, and 1-2 months of participation.
Who is the study for?
This trial is for adults aged 18-65 with certain psychiatric conditions like depression, bipolar disorder, or PTSD. It's also open to healthy individuals without any DSM-5 diagnosis. Participants must be English-speaking and medication-free or on approved meds for at least two weeks.
What is being tested?
The study examines the glutamate system in mental health by using PET scans, MRI imaging, and cognitive tests over 1-2 months. The goal is to understand how this system differs among those with psychiatric disorders compared to healthy controls.
What are the potential side effects?
While not a treatment trial, procedures may include discomfort from lying still during scans, potential anxiety from enclosed spaces in MRI machines, and exposure to radiation within FDA limits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken any medication for the last 2 weeks or only allowed medications for depression.
Select...
I am currently experiencing a depressive episode.
Select...
I have been diagnosed with PTSD according to DSM-5 criteria.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a bleeding disorder or am on blood thinners like Coumadin.
Select...
I am currently experiencing strong thoughts of harming myself.
Select...
I am currently pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive TestingExperimental Treatment1 Intervention
Cognitive assessments
Group II: Magnetic Resonance ImagingActive Control1 Intervention
All subjects will have one MRI with a possibility of one functional MRI (fmri).
Group III: Positron Emission TomographyActive Control1 Intervention
All subjects will have PET scan using FPEB or ABP688.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Testing
2020
N/A
~40
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,264 Total Patients Enrolled
VA Office of Research and DevelopmentFED
1,666 Previous Clinical Trials
3,765,629 Total Patients Enrolled
Irina Esterlis, PhDPrincipal InvestigatorYale School of Medicine
3 Previous Clinical Trials
299 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I haven't taken any medication for the last 2 weeks or only allowed medications for depression.I haven't taken any medication in the last 2 weeks or only allowed medications for PTSD.You must be able to speak English.I haven't taken any medication in the last 2 weeks or only allowed medications.I am currently experiencing a depressive episode.You cannot have any other medical conditions listed in the DSM-5 manual, except for those specifically required for this study.I have been diagnosed with PTSD according to DSM-5.I am currently experiencing a depressive episode.I have a bleeding disorder or am on blood thinners like Coumadin.I have been diagnosed with PTSD according to DSM-5 criteria.I am currently experiencing strong thoughts of harming myself.I am currently pregnant or breastfeeding.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Testing
- Group 2: Magnetic Resonance Imaging
- Group 3: Positron Emission Tomography
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT02727972 — N/A