Ketamine Treatment of Youth Suicide Attempters
2 other identifiers
interventional
60
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2022
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedStudy Start
First participant enrolled
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
March 20, 2026
March 1, 2026
4.2 years
February 12, 2021
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of remission of suicidal symptoms at the end of treatment.
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.
Up to 3 months post-discharge
Secondary Outcomes (2)
Number of CAMS sessions needed to achieve enduring mental state
Up to 3 months post-discharge
Change of Beck Scale for Suicide Ideation score will be analyzed
Up to 3 months post-discharge
Study Arms (2)
Ketamine Treatment + CAMS Therapy
EXPERIMENTALSaline Placebo Treatment + CAMS Therapy
PLACEBO COMPARATORInterventions
CAMS weekly sessions will also be started immediately as an inpatient at the start of the study while receiving ketamine or saline. CAMS will be continued weekly after the patient is discharged and followed up as an outpatient. Weekly CAMS sessions will be terminated after the subject, as an outpatient, 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).
Ketamine hydrochloride will be given as an intravenous infusion using a standard regimen given in most studies conducted: 0.5 mg/kg over 40 minutes. Ketamine infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.
Subjects randomized to placebo will be administered a saline (0.9% sodium chloride) drip for 40 minutes. Saline placebo infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Mental Health (NIMH)collaborator
- Massachusetts General Hospitalcollaborator
- Tatiana Falcone, MDlead
- National Institutes of Health (NIH)collaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tatiana Falcone, M.D.
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double Blind, Placebo Controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Staff, Cleveland Clinic
Study Record Dates
First Submitted
February 12, 2021
First Posted
February 21, 2021
Study Start
June 27, 2022
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03