Ketamine Treatment of Youth Suicide Attempters

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14-30
SponsorTatiana Falcone, MD

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Ketamine Hydrochloride
  • Saline
  • CAMS Therapy

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tatiana Falcone, MD

Lead sponsor

The Cleveland Clinic

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Massachusetts General Hospital

Collaborator