Ketamine treatment for young people who have attempted suicide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: deiszc@ccf.org
• Phone: (440) 225-6193

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.