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NMDA Receptor Antagonist

Ketamine for Depression (G2K Trial)

Phase 2

Waitlist Available

Led By Balwinder Singh, M.D., M.S.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets diagnostic criteria for major depressive disorder without psychotic features per the SCID DSM-IV-TR

Be older than 18 years old

Must not have

ECT in the past 6 months

A history of bleeding in the brain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to the end of 40-minute infusion for gaba and glu. baseline to 24 hours post-infusion for madrs

Summary

This trial aims to understand how levels of certain brain chemicals change during a ketamine infusion compared to a saline infusion in adults with treatment-resistant depression. The study will use brain imaging and blood tests to measure

Who is the study for?

This trial is for adults with treatment-resistant depression, which means their condition hasn't improved after trying other medications. Participants must be diagnosed with Major Depressive Disorder and not have schizophrenia.

What is being tested?

The study tests if Ketamine given through an IV can help improve symptoms of depression compared to a saline solution (salt water). Researchers will measure changes in brain and blood chemicals related to mood before and after the infusion.

What are the potential side effects?

Ketamine may cause side effects like disorientation, nausea, increased blood pressure, hallucinations, or dizziness during or shortly after the infusion. Long-term side effects are not well understood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major depression without psychosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had electroconvulsive therapy in the last 6 months.

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I have had bleeding in my brain before.

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I have had a brain injury that caused me to lose consciousness.

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I have been diagnosed with Complex Regional Pain Syndrome.

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I have had a bad reaction or no improvement from ketamine treatment before.

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I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or have active psychotic symptoms.

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I cannot give consent and do not have a legal guardian.

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My BMI is over 40.

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I take more than 2 mg of lorazepam or any benzodiazepine in the morning daily.

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I have not taken any opioid blockers in the last two weeks.

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I am currently receiving TMS, vagal nerve, or deep brain stimulation for depression.

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I have had grand mal seizures.

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I have been diagnosed with delirium or a similar condition in the last year.

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I have or had an abnormal connection between arteries and veins or a bulging blood vessel.

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I have not had severe liver problems, a liver transplant, or been diagnosed with cirrhosis in the last year.

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My acid reflux is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the end of 40-minute infusion for gaba and glu. baseline to 24 hours post-infusion for madrs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to the end of 40-minute infusion for gaba and glu. baseline to 24 hours post-infusion for madrs

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of 40-minute infusion for gaba and glu. baseline to 24 hours post-infusion for madrs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in peripheral Gamma-Aminobutyric Acid and Glutamate levels

Change in the Montgomery Asberg Depression Rating Scale

Correlation between the percent change in central (anterior cingulate cortex) Gamma-Aminobutyric Acid and Glutamate levels and the change in depression severity measured using the Montgomery-Åsberg Depression Rating Scale

+2 more

Secondary study objectives

Change in Beck Scale for Suicidal Ideation

Change in Clinical Global Impression

Change in McIntyre And Rosenblat Rapid Response Scale

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ketamine GroupExperimental Treatment1 Intervention

Subjects will receive IV racemic ketamine at a dose of 0.5 mg per kg of the participant's actual body weight, with a maximum dose of 50 mg for individuals weighing over 100 kg.

Group II: Normal Saline/Placebo GroupPlacebo Group1 Intervention

Subjects will receive an IV infusion of normal saline over a duration of 40 minutes

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1120

0 / 17Eligibility criteria met