Actively Recruiting

Phase 3
Age: 14Years - 30Years
All Genders
NCT04763343

Ketamine Treatment of Youth Suicide Attempters

Led by Tatiana Falcone, MD · Updated on 2026-03-20

60

Participants Needed

2

Research Sites

218 weeks

Total Duration

On this page

Sponsors

T

Tatiana Falcone, MD

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Ketamine Treatment of Youth Suicide Attempters

Who Can Participate

Age: 14Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must be 14 to 30 years of age
  • Subjects must have been admitted to Cleveland Clinic Hospital (Fairview or Lutheran Hospital) after a suicide attempt with continued suicidal ideation or unable to contract for safety
  • Subjects must have a clinical rated Scale for Suicidal Ideation (SSI) score of 6 or higher
  • Subjects must be able to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Subjects with known history of autistic spectrum disorder or non-verbal
  • Subjects with moderate or severe intellectual disability (IQ less than 70 or in full-time special education)
  • Subjects with schizophrenia or any history of psychosis including mood disorder related psychosis
  • Positive urine toxicology for phencyclidine, cocaine, or amphetamines within 6 months before screening (excluding prescribed amphetamines for ADHD)
  • History of moderate or severe substance or alcohol use disorder in the past 6 months
  • Any contraindication to ketamine including allergy or medical/neurological conditions
  • Current pregnancy or breastfeeding
  • Previous recreational ketamine use or excessive prior therapeutic ketamine use
  • History of hypertension, myocardial infarction, congestive heart failure Stage 2 or higher, angina, or prolonged QTcF interval
  • Subjects in custody of Children's Services

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

The Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

C

Christina Deisz, LISW-S

CONTACT

T

Tatiana Falcone, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Ketamine Treatment of Youth Suicide Attempters | DecenTrialz