Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine

This Phase II interventional trial (n=66) aims to evaluate the safety, efficacy, and connectome phenotypes of intravenous ketamine in reducing suicidal thinking in adolescents with treatment-resistant depression (TRD) and a recent history of a suicide event.

Conducted by Yale University and led by Michael Bloch, MD MS, the study commenced on January 21, 2022, and is estimated to complete by March 2025.

Adolescents aged 13 to 17, meeting DSM-5 criteria for Major Depressive Disorder, will receive either four ketamine infusions over two weeks or an active control, midazolam, with follow-up for four months.

The primary outcome measure is the reduction in suicidal ideation, assessed via the Columbia-Suicide Severity Rating Scale (C-SSRS), 48 hours after the first administration. Secondary outcome measures include the Montgomery Asberg Depression Rating Scale and the Children’s Depression Rating Scale-Revised.

The study aims to determine safety, efficacy, and predictors of response using functional neuroimaging, contributing to personalised medicine for adolescent depression treatment.

Topic Treatment-Resistant Depression Suicidality Depression Adolescence and Psychedelics
Compound Ketamine
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

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