Ketamine Treatment of Youth Suicide Attempters

Last updated: March 18, 2026
Sponsor: Tatiana Falcone, MD
Overall Status: Active - Recruiting

Phase

3

Condition

Suicide

Treatment

Ketamine Hydrochloride

CAMS Therapy

Saline

Clinical Study ID

NCT04763343
21-154
1R01MH125214-01
  • Ages 14-30
  • All Genders

Study 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 60 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must be 14 to 30 years of age

  • Subjects must have been admitted to Cleveland Clinic Hospital (Fairview or LutheranHospital) after a suicide attempt (any intentional, non-fatal self- injuryregardless of medical lethality, if intent to die was indicated) with continuedsuicidal ideation or endorsing ongoing suicidal ideation and unable to contract forsafety placing them at an increased risk to attempt suicide. Subjects will need aclinical rated Scale for Suicidal Ideation (SSI) score ≥ 6.

  • Subjects must have the ability to understand and the willingness to sign a writteninformed consent document.

Exclusion

Exclusion Criteria:

  • Subjects with known history of autistic spectrum disorder; non-verbal patients.

  • Subjects with moderate or severe intellectual disability (IQ less than 70 and thosepatients in special education full-time).

  • Subjects with schizophrenia or history of any type of psychosis including mooddisorder related psychosis and brief reactive psychosis.

  • Within 6 months before initial screening, urine toxicology positive forphencyclidine, cocaine or amphetamines (subjects prescribed amphetamines formanagement of ADHD will not be excluded)

  • Subjects with history of moderate or severe substance or alcohol use per DSM- Vcriteria in the past 6 months.

  • Subjects with any contraindication to ketamine such as allergic reaction to ketamineor medical or neurological condition with a contraindication for use of ketamine oron any drugs associated with significant interaction with ketamine.

  • Subjects who are currently pregnant and/or breast feeding.

  • Subjects with previous recreational ketamine use. Subjects with previous therapeuticKetamine use that exceeds the maximum cumulative lifetime exposure of 60 mg dailyand 8 administrations maximum (or 480 mg) during both previous treatment and theproposed inclusion of this study.

  • Subjects with hypertension, history of myocardial infarction, congestive heartfailure of Stage 2 or higher, angina, or QTcF of at least 450 msec as indicated bychart review and/or standard of care EKG performed upon admission to inpatient unit.

  • Subjects in the custody of Children's Services.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Ketamine Hydrochloride
Phase: 3
Study Start date:
June 27, 2022
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • The Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • The Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.