Ketamine Treatment of Youth Suicide Attempters

Suicide, Attempted Clinical Trial

Official title: Ketamine Treatment of Youth Suicide Attempters for Fast Reduction of Severe Suicide Risk and Facilitation of Long-term Collaborative Clinical Engagement: A Double Blind Randomized Placebo Controlled Trial

Status Recruiting

Clinical Trial Summary

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 of<4, and >50% 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).

Clinical Trial Description

Suicide is the second leading cause of death in 15-24 year-olds and accounts for 13% of all adolescent deaths annually. According to the CDC, the suicide rate for 10-24 year-olds increased in the last decade, with the suicide rate for 10-14 year-olds, 15-18 year-olds, and 20-24 year-olds increasing 177%, 76%, and 36%, respectfully. There is a critical need to develop fast and effective treatment in this highest-risk age group. Therefore, there is an urgent need to develop rapid, safe and feasible treatment to decrease suicidality in youth admitted to inpatient psychiatry after a serious suicidal attempt.

This proposal seeks to address this critical clinical gap by conducting an inpatient trial of treatment with ketamine vs placebo (saline) for rapid reversal of patients' suicidal state. Furthermore, this study will also test whether ketamine facilitates the effectiveness of collaborative psychotherapy for an enduring anti-suicidal response. One hundred and forty subjects who are medically stable admitted to inpatient psychiatry after a serious suicide attempt (defined as any act of self-harm with an intent to die) with continued suicidal ideation will be included in the study. After initial assessment, in conjunction with an anesthesiologist for any contraindication of using ketamine, patients will be randomized to receive either ketamine infusion 0.5 mg/kg over 40 minutes or saline. Ketamine or saline infusions on alternate days over two weeks will be given until subject reports no suicidal ideation for three consecutive sessions, or a maximum administration of six infusions is reached, or until they are discharged from the hospital. Concurrently, weekly sessions of CAMS will be started and continued as an outpatient after the patient is discharged until the subject also reports no suicidal ideation as an outpatient for three consecutive sessions. Monthly assessments for suicidal ideation, attempts and readmissions will be conducted as an outpatient for 3 months. ;

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

• NCT number: NCT04763343
• Study type: Interventional
• Source: The Cleveland Clinic
• Contact: Christina Deisz, LISW-S
• Phone: (440) 225-6193
• Email: deiszc@ccf.org
• Status: Recruiting
• Phase: Phase 3
• Start date: June 27, 2022
• Completion date: August 2024