RecruitingPhase 3
Ketamine Treatment of Youth Suicide Attempters
NCT04763343 · Tatiana Falcone, MD
Recruiting
Status
Accepting participants
Phase 3
Phase
60
Target enrolment
1
Study sites
1 US states
What it is testing
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).
Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.
What counts as success
Primary outcome measures
Rate of remission of suicidal symptoms at the end of treatment.
Measured over Up to 3 months post-discharge
A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.
Who can take part
Eligibility, as published
14 Years to 30 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.
Where
1 study site
| Facility | City | Region | Country |
|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | United States |
On the registry
Contact the trial directly
This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.
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NCT04763343 on ClinicalTrials.gov →
Last updated in the registry 2026-07-16. Registry records change; this page reflects the data build of 2026-08-25.
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