Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment

This open-label trial (n=15) will assess the safety and tolerability of a single sub-anesthetic (35mg/70kg) intravenous (IV) ketamine treatment in individuals aged 50-90 with mild cognitive impairment and depression (MCI-D).

It aims to determine whether treatment with a single dose of ketamine may improve mood or cognition in individuals with MCI-D. The study also explores the influence of Alzheimer’s disease biomarker status on the effectiveness of ketamine treatment and examines brain connectivity changes after ketamine treatment. The study involves screening, a baseline visit, a single infusion of IV ketamine, and follow-up visits over approximately one month.

Primary outcome measures include the number and severity of symptom events assessed by the Patient Rated Inventory of Side Effects (PRISE), and secondary outcome measures include depressive symptoms assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) and cognition assessed with the NIH Toolbox Cognition Battery.

The study is conducted by the Icahn School of Medicine at Mount Sinai, with Rachel Fremont as the principal investigator. Recruitment is ongoing in New York, New York, United States, and the study started on October 18, 2023, with an estimated completion date in December 2025.

Topic Depression
Compound Ketamine
Country United States of America
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Icahn School of Medicine at Mount Sinai
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