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