Actively Recruiting
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
Eligibility Criteria
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
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
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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