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NOT YET RECRUITING
NCT06698848
PHASE1

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-01-01

Completion Date

2030-06-30

Last Updated

2024-11-21

Healthy Volunteers

Yes

Interventions

DRUG

ketamin

Participants in this study will have been diagnosed with major depressive episode (MDE) and have not received any psychiatric treatment for at least 2 weeks (5 weeks if on fluoxetine).Patients will receive intravenous ketamine as the only study drug treatment for the 2 weeks of the study. Magnetic Resonance Imaging (MRI) will be used to measure effects of ketamine on brain structure, function and chemistry, in addition to a soft-nasal brushing procedure to obtain olfactory sensory neurons which will provide the ability to profile in vivo how neurons may react to KET treatment in depressed patients.

Locations (1)

Massachusetts General Hosipital

Boston, Massachusetts, United States