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
Visit trial
Status Recruiting
Results Published No
Start date 21 January 2022
End date 31 March 2025
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 66
Sex All
Age 13- 17
Therapy Yes

Trial Details

The purpose of this study is to determine if intravenous ketamine reduces suicidal thinking compared to an active placebo (midazolam) in adolescents who have treatment resistant depression and a recent history of a suicide event (defined as a suicide attempt, emergency room evaluation for suicidal thinking, or a transition to inpatient care for suicidality in the past 120 days). The primary objective of this study is to determine whether ketamine reduces suicidal ideation (as measured via the C-SSRS, recent ideation scale) relative to an active control, midazolam, 48-hours after first administration in adolescents with TRD at high suicide risk.

NCT Number NCT04613453

Sponsors & Collaborators

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

Data attribution

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