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Phase 2
Age: 18Years - 55Years
All Genders
ID02122562

Study of Ketamines Antidepressant Effects in Adults with Treatment-Resistant Major Depression Comparing Those With and Without a Family History of Alcohol Use Disorder Using Brain Imaging During Treatment

Led by Mark Niciu · Updated on 2026-05-01

60

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the antidepressant effects of a single subanesthetic dose of ketamine in adults aged 18 to 55 years with treatment-resistant major depressive disorder TRD. The study focuses on how a family history of alcohol use disorder FHP may influence ketamines antidepressant response compared to those without such a history FHN. Ketamine and alcohol both act on NMDA receptors, and the study aims to understand ketamines improved efficacy in patients with FHP by measuring glutamate release in the brain. The study has two phases an initial medication taper and a psychotropic medication-free period lasting at least two weeks, followed by a ketamine infusion phase. Participants receive one ketamine infusion at a dose of 0.5 mgkg over 40 minutes during 7T magnetic resonance imaging MRI, including resting-state functional MRI and magnetic resonance spectroscopy to observe glutamate levels in specific brain regions. The study includes 50 subjects divided equally between those with and without a family history of alcohol use disorder. During the study, participants undergo clinical assessments such as the Montgomery-sberg Depression Rating Scale MADRS to measure depression severity before and one week after ketamine infusion. Additional evaluations include various psychiatric rating scales and monitoring of glutamate changes and brain connectivity via MRI. The studys primary goal is to compare antidepressant effects and brain glutamate responses between the two groups, contributing to more personalized treatments for major depression. Total participation includes the medication taper, drug-free period, ketamine infusion, and follow-up assessments.

CONDITIONS

Brief Title

Ketamine Alcohol (in Treatment-Resistant Depression)

Research Team

O

Osura R Amarajeewa, M.B.B.S.

M

Mark J Niciu, M.D. Ph.D.

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