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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 up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

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.

0 / 6Eligibility criteria met