Ketamine for Depression

(G2K Trial)

Overseen By Nicole Reinicke

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Benzodiazepines, MAOIs, Opioid antagonists, others

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to to evaluate the relationships between peak (% change from baseline) central GABA and Glu levels during a 40-min IV ketamine or normal saline infusion utilizing fMRS, and change in peripheral GABA and Glu levels from baseline to 24-hr postinfusion utilizing LCMS, with baseline to 24-hr post-infusion change in depression (MADRS) in 30 TRD adults.

Research Team

Balwinder Singh, M.D., M.S.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide informed consent

PHQ-9 total score ≥ 15 at screening

Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and criteria

Exclusion Criteria

I have had bleeding in my brain before.

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

I have been diagnosed with Complex Regional Pain Syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 40-minute IV infusion of either racemic ketamine or normal saline in an MRI scanner

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in depression severity and biochemical markers up to 24 hours post-infusion

1 day

1 visit (in-person)

Open-label extension (optional)

Participants may opt into an additional open-label ketamine infusion

Treatment Details

Interventions

• Ketamine

Trial Overview 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.

Participant Groups

Group I: Ketamine Group Experimental Treatment 1 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 Group Placebo Group 1 Intervention

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

Ketamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+