Status:
RECRUITING
Ketamine Treatment of Youth Suicide Attempters
Lead Sponsor:
Tatiana Falcone, MD
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Conditions:
Suicide, Attempted
Eligibility:
All Genders
14-30 years
Phase:
PHASE3
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...
Detailed Description
Suicide is the second leading cause of death in 15-24 year-olds and accounts for 13% of all adolescent deaths annually. According to the CDC, the suicide rate for 10-24 year-olds increased in the last...
Eligibility Criteria
Inclusion
- Subjects must be 14 to 30 years of age
- Subjects must have been admitted to Cleveland Clinic Hospital (Fairview, Marymount, or Lutheran Hospital) or Massachusetts General Hospital (Blake 11) 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.
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04763343
Start Date
June 27 2022
End Date
August 31 2026
Last Update
September 22 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
2
The Cleveland Clinic
Cleveland, Ohio, United States, 44195