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

This open-label, interventional trial (n=120) will investigate the effects of intravenous ketamine (35mg/70kg over 40 minutes, maximum dose 60mg) on brain function, structure, and molecular signatures in patients with major depressive disorder (MDD).

Conducted by Massachusetts General Hospital and led by Dr Amit Anand, this study aims to elucidate ketamine’s rapid antidepressant and anti-suicidal effects by correlating molecular and gene expression changes in olfactory neurons with alterations in brain connectivity.

Participants will include 90 medication-free individuals with MDD and 30 healthy controls, undergoing structural and functional MRI scans, diffusion-weighted imaging, and olfactory neuron sampling before and after three alternate-day ketamine infusions. The findings may provide novel insights into ketamine’s mechanism of action and inform the development of new antidepressant therapies.

Topic Neuroscience Healthy Subjects Depression
Compound Ketamine
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 January 2025
End date 30 June 2030
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 120
Sex All
Age 18- 50
Therapy No

Trial Details

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.

Trial Number NCT06698848

Sponsors & Collaborators

Massachusetts General Hospital
Massachusettes General Hospital has launched the MGH Center for the Neuroscience of Psychedelics. The announcement has now been done via YouTube, and the formal launch will be in fall 2020.

Data attribution

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