Could ketamine be a fast-acting lifeline for suicidal teens and young adults?
NCT ID NCT04763343
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study tests whether ketamine, given as an IV infusion, can quickly lower severe suicide risk in young people aged 14 to 30 who have just attempted suicide. Participants receive either ketamine or a placebo while in the hospital, plus weekly therapy sessions. The goal is to see if ketamine helps reduce suicidal thoughts faster and keeps patients engaged in follow-up care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 30 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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