Ketamine Treatment of Youth Suicide Attempters

This double-blind, placebo-controlled trial (n=140) investigates the efficacy and safety of ketamine in rapidly reducing severe suicide risk among youth aged 14-30 who have attempted suicide.

Conducted by Tatiana Falcone, MD, at The Cleveland Clinic and Massachusetts General Hospital, the study aims to address the critical need for fast and effective treatments in this high-risk age group.

Participants will be randomly assigned to receive either ketamine or saline infusions while admitted to inpatient psychiatry. Weekly sessions of Collaborative Assessment for the Management of Suicidality (CAMS) will also be conducted.

The primary outcome measure is the rate of remission of suicidal symptoms at the end of treatment, with secondary measures including the number of CAMS sessions needed to achieve enduring mental stability and changes in the Beck Scale for Suicidal Ideation score.

The study, expected to complete enrolment by June 2024, is funded by the National Institutes of Health (NIH) and is a phase III intervention trial.

Trial Details

Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 140 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk < 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).

NCT Number NCT04763343

Data attribution

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