Ketamine Treatment of Youth Suicide Attempters

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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 15-24. 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 140 youth between the ages 15- 24 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, as an outpatient, 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, for at least 3 consecutive sessions of CAMS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tatiana Falcone, MD
• Collaborators: Massachusetts General Hospital; National Institute of Mental Health (NIMH); National Institutes of Health (NIH)
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Subjects must be 15 to 24 years of age

• Subjects must have been admitted to the hospital inpatient unit after a suicide attempt (any intentional, non-fatal self- injury regardless of medical lethality, if intent to die was indicated) and continued to express suicidal ideation. Also at time of screening clinician rated Scale for Suicidal Ideation (SSI) score should be ≥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.

• Subjects diagnosed with cluster B personality disorder e.g.borderline personality

• Subjects with a history of recurrent self-harm gestures or self-mutilating behaviors without suicidal intent as judged by psychiatrist

• Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines

• 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 with BMI > 30 as ketamine is given by weight and high doses of ketamine need to be avoided.

• Subjects who are currently pregnant and/or breast feeding.