Integrating Ketamine Effects on Neuronal Molecular Signatures and the Brain Functional and Structural Connectome

Running, not enrolling · Phase 1

Conditions studied: Depression, Suicide

In brief

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.

Key facts

Study ID

NCT06698848

Run by

Massachusetts General Hospital

People needed

120

Starts

2025-01-01

Expected to finish

2030-06-30

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 1. Able to give voluntary informed consent; 2. Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for Major Depression Disorder (MDD) 3. Currently in a depressive episode (MDE); 4. Montgomery and Asberg Depression Rating Scale (MADRS) score >21 but <32(moderate to severe depression)11; 3. Psychotropic medication-free > 2weeks and if on fluoxetine then for >5 weeks at time of inclusion in the study(no taper or medication washout will be done for the purpose of the study). 6. Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire; 7) able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale < 5 (i.e., moderately ill) and no suicidal/homicidal intent or behavior or gross disability; and 8) no contraindication to KET treatment such as KET allergy or uncontrolled hypertension.

You may not qualify if…

• 1. Meeting DSM-5 criteria for (hypo)mania, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, intellectual disability, or pervasive developmental disorder; 2. History of receiving electroconvulsive therapy in the past 1 year (due to possible effects on brain morphology); 3. Meeting DSM-5 criteria for moderate or severe substance/alcohol use within the past 6 months excluding caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening. The typical weekly use of caffeine, nicotine and alcohol will be recorded; 4. No serious medical or neurological illness, including previously known HIV positive status (due to possible CNS involvement) as assessed by history, physical examination and laboratory examination including EKG, CBC and blood chemistry; 5. Current pregnancy or breast feeding; 6. Metallic implants or contraindication to MRI.

Where it is running

• Massachusetts General Hosipital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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