Ketamine treatment for young people who have attempted suicide

Ketamine Treatment of Youth Suicide Attempters for Fast Reduction of Severe Suicide Risk and Facilitation of Long-term Collaborative Clinical Engagement: A Double Blind Randomized Placebo Controlled Trial

This study is testing if ketamine can quickly help young people aged 14-30 who have recently tried to take their own lives feel less suicidal while they are in psychiatric care.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 14 Years to 30 Years
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT04763343 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of ketamine, an NMDA antagonist, to rapidly reduce suicidal ideation in youth aged 14-30 who have recently attempted suicide. The study will enroll 62 participants who will be randomly assigned to receive either ketamine or a placebo saline infusion while admitted to inpatient psychiatric care. The treatment aims to assess the safety and efficacy of ketamine in this high-risk population, with the potential to enhance the effectiveness of collaborative psychotherapy for long-term anti-suicidal effects. Participants will receive up to six infusions over two weeks, with careful monitoring for safety and response.

Who should consider this trial

Good fit: Ideal candidates are youth aged 14-30 who have been admitted to a psychiatric facility after a suicide attempt and continue to experience suicidal ideation.

Not a fit: Patients with a history of autism spectrum disorder, severe intellectual disabilities, or psychosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a rapid and effective intervention for reducing suicidal thoughts in at-risk youth.

How similar studies have performed: Previous studies in adults have shown promising results for ketamine in reducing suicidal ideation, suggesting potential for success in this novel application for youth.

Eligibility criteria

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 this trial is running

Boston, Massachusetts and 1 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• The Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Tatiana Falcone, M.D. — The Cleveland Clinic
• Study coordinator: Christina Deisz, LISW-S

Conditions: Suicide, Attempted