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Ketamine Treatment for Youth After Suicide Attempt

This study is looking at whether ketamine can help young people (ages 14-30) who have recently attempted suicide and are still having suicidal thoughts. Participants will receive either ketamine hydrochloride or a saline (saltwater) placebo through an IV every other day. Everyone in the study will also receive CAMS Therapy (a type of counseling) weekly. The main goal is to see how many participants experience a significant reduction in suicidal symptoms by up to three months after leaving the hospital. The study plans to enroll 60 participants and is currently unclear about its recruitment status. This research aims to find quick and effective treatments for this high-risk group.

Study design
This is an interventional study planning to enroll 60 participants. Participants will be randomly assigned to receive either ketamine or saline.
What's involved
You would receive IV infusions of either ketamine or saline every other day until your suicidal ideation score drops below a certain level. You would also attend weekly CAMS therapy sessions, starting as an inpatient and continuing as an outpatient.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the remission of suicidal symptoms up to 3 months after you are discharged from the hospital.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04763343

Ketamine Treatment of Youth Suicide Attempters

Recruiting
PHASE3Ages 14–30InterventionalTreatment
Tatiana Falcone, MD
~60 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Ketamine HydrochlorideSalineCAMS Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of remission of suicidal symptoms at the end of treatment.
Measured over Up to 3 months post-discharge

Conditions

Suicide, Attempted

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NCT04763343

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tatiana Falcone, M.D. · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Christina Deisz, LISW-S
[email protected]
(440) 225-6193
Email the study team

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Eligibility criteria

Inclusion

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 (any intentional, non-fatal self- injury regardless of medical lethality, if intent to die was indicated) with continued suicidal ideation or endorsing ongoing suicidal ideation and unable to contract for safety placing them at an increased risk to attempt suicide. Subjects will need a clinical rated Scale for Suicidal Ideation (SSI) score ≥ 6.
Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion

Subjects with known history of autistic spectrum disorder; non-verbal patients.
Subjects with moderate or severe intellectual disability (IQ less than 70 and those patients in special education full-time).
Subjects with schizophrenia or history of any type of psychosis including mood disorder related psychosis and brief reactive psychosis.
Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (subjects prescribed amphetamines for management of ADHD will not be excluded)
Subjects with history of moderate or severe substance or alcohol use per DSM- V criteria in the past 6 months.
Subjects with any contraindication to ketamine such as allergic reaction to ketamine or medical or neurological condition with a contraindication for use of ketamine or on 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 therapeutic Ketamine use that exceeds the maximum cumulative lifetime exposure of 60 mg daily and 8 administrations maximum (or 480 mg) during both previous treatment and the proposed inclusion of this study.
Subjects with hypertension, history of myocardial infarction, congestive heart failure of Stage 2 or higher, angina, or QTcF of at least 450 msec as indicated by chart review and/or standard of care EKG performed upon admission to inpatient unit.
Subjects in the custody of Children's Services.

What this trial measures

  • Rate of remission of suicidal symptoms at the end of treatment.Up to 3 months post-discharge

    Remission of suicide symptoms will be defined by a 50% or greater reduction in the clinician-rated baseline Beck Scale for Suicidal Ideation (SSI) score, and SSI score less than the score of 4. SSI scores can range from 0 to 38, and a higher score indicates increased severity of suicidal ideation. The primary outcome of the remission rate will be compared between the two groups.