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NMDA Receptor Antagonist

Ketamine Imaging for Mood Disorders

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
Subjects undergoing ketamine treatment must meet DSM-5 diagnostic criteria for Major Depressive Disorder and for a current depressive episode as assessed by structured interview for DSM-5 diagnosis (SCID) and be undergoing ketamine treatment
Be older than 18 years old
Must not have
Lifetime history of neurologic abnormality including seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia >24 hours
Contraindications to PET (e.g., past or current diagnosis of cancer, poor venous access for placement of venous lines)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion date, an average of 5 years.
Awards & highlights

Summary

This trial is designed to study the effects of ketamine on synaptic density in people with depression or PTSD.

Who is the study for?
This trial is for adults aged 18-70 with Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), who understand the study's research nature. Healthy individuals without any DSM-5 diagnosis can also participate. Exclusions include neurological issues, low IQ, substance abuse, certain medical conditions, and contraindications to MRI or PET scans like claustrophobia.Check my eligibility
What is being tested?
The study investigates how ketamine affects synaptic density in people with MDD and PTSD using imaging techniques like MRI and PET scans. Participants will undergo cognitive tests and a stress test on scan days to see if ketamine can reverse changes associated with these disorders.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of ketamine may include confusion, hallucinations, changes in blood pressure, dizziness, nausea, and blurred vision during the short-term post-administration period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diagnosed with Major Depressive Disorder and currently receiving ketamine treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had a major brain condition, injury, or long-term memory loss.
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I cannot have a PET scan due to past cancer or issues with my veins.
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I have been diagnosed with major depression or PTSD with psychotic features.
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I weigh less than 110 lbs.
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I have a bleeding disorder or am currently on blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion date, an average of 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion date, an average of 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evidence of synaptic changes in psychiatric disorders confirmed by PET data.
Evidence of synaptic density at time of its greatest anti-depressant response in psychiatric disorders confirmed with PET data.

Trial Design

3Treatment groups
Active Control
Group I: PET scans for subjects undergoing ketamine treatmentActive Control1 Intervention
For subjects currently undergoing treatment with ketamine. Subjects will participate in 1-3 PET scans (up to 4 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan. Baseline scan will occur prior to initiation of ketamine treatment. Subsequent scans will occur after several treatments with ketamine and after completion of treatment. Bipolar subjects will not participate in any ketamine arms.
Group II: PET scans and ketamine administrationActive Control1 Intervention
Subjects will participate in 2-3 PET scans (up to 4 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan. After a baseline scan, subjects will be administered a low dose of ketamine for the second scan. Bipolar subjects will not participate in any ketamine arms.
Group III: Single PET scanActive Control1 Intervention
Subjects will participate in 1 PET scan (up to 2 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentFED
1,628 Previous Clinical Trials
3,325,849 Total Patients Enrolled
78 Trials studying Depression
20,733 Patients Enrolled for Depression
Yale UniversityLead Sponsor
1,874 Previous Clinical Trials
2,953,426 Total Patients Enrolled
64 Trials studying Depression
20,646 Patients Enrolled for Depression
Irina Esterlis, PhDPrincipal Investigator - Yale School of Medicine
Yale University
3 Previous Clinical Trials
349 Total Patients Enrolled

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02734602 — N/A
Depression Research Study Groups: PET scans for subjects undergoing ketamine treatment, PET scans and ketamine administration, Single PET scan
Depression Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT02734602 — N/A
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02734602 — N/A
Depression Patient Testimony for trial: Trial Name: NCT02734602 — N/A
~29 spots leftby Jan 2027