Ketamine Treatment of Youth Suicide Attempters

PHASE3RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 27, 2022

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Suicide, Attempted
Interventions
DRUG

Ketamine Hydrochloride

Ketamine hydrochloride will be given as an intravenous infusion using a standard regimen given in most studies conducted: 0.5 mg/kg over 40 minutes. Ketamine infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.

DRUG

Saline

Subjects randomized to placebo will be administered a saline (0.9% sodium chloride) drip for 40 minutes. Saline placebo infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.

BEHAVIORAL

CAMS Therapy

CAMS weekly sessions will also be started immediately as an inpatient at the start of the study while receiving ketamine or saline. CAMS will be continued weekly after the patient is discharged and followed up as an outpatient. Weekly CAMS sessions will be terminated after the subject, as an outpatient, 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).

Trial Locations (2)

44195

RECRUITING

The Cleveland Clinic, Cleveland

02115

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

Massachusetts General Hospital

OTHER

lead

Tatiana Falcone, MD

OTHER