Ketamine for Depression

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

Subanesthetic dose of intravenous ketamine (KET) has been found to be highly effective in rapid treatment depression and associated suicidality but its exact mechanism of remains uncertain. This study will use a novel approach to elucidate KET's effects on the molecular/ gene expression pathways in living neurons obtained from the olfactory epithelium and correlate the changes to rapid improvement in depression via changes in the brain connectome. The study will identify the molecular targets and pathways involved in KET'S mechanism of rapid clinical action and pave the way for development of novel, more efficacious, and safer therapeutic agents.

Eligibility Criteria

This trial is for individuals experiencing depression, self-harm tendencies, or suicidal thoughts. Specific eligibility criteria are not provided but typically include factors like age range, severity of symptoms, and absence of certain medical conditions.

Inclusion Criteria

Able to give voluntary informed consent

Currently in a depressive episode

I have been diagnosed with Major Depression Disorder.

Exclusion Criteria

I have not had electroconvulsive therapy in the last year.

Meeting DSM-5 criteria for (hypo)mania, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, intellectual disability, or pervasive developmental disorder

Meeting DSM-5 criteria for moderate or severe substance/alcohol use within the past 6 months (excluding caffeine or nicotine)

Treatment Details

Interventions

• Ketamine (NMDA Receptor Antagonist)

Trial Overview The study investigates how a low dose of ketamine given through an IV can quickly relieve depression and prevent suicide. It looks at changes in genes within neurons from the nose and links them to brain connectivity improvements observed via imaging techniques.

Participant Groups

Group I: Intravenous Ketamine Experimental Treatment 1 Intervention

Intravenous ketamine will be given at a dose of 0.5 mg/kg over 40 minutes with a maximum dose of 60 mg.

Ketamine is already approved in Canada for the following indications:

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+