Ketamine Treatment of Youth Suicide Attempters
ConditionSuicide, Attempted
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ketamine Hydrochloride
DrugKetamine 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.
Saline
DrugSubjects 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.
CAMS Therapy
BehavioralCAMS 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).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Ketamine Treatment + CAMS TherapyExperimental treatment 2 interventions
Group B: Saline Placebo Treatment + CAMS TherapyPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Rate of remission of suicidal symptoms at the end of treatment.
Remission of suicide symptoms will be defined by a 50% or greater reduction in the clinician-rated baseline Beck Scale for Suicidal Ideation (SSI) score, and SSI score less than the score of 4. SSI scores can range from 0 to 38, and a higher score indicates increased severity of suicidal ideation. The primary outcome of the remission rate will be compared between the two groups.
Time frame
Up to 3 months post-dischargeSecondary outcomes
1
Number of CAMS sessions needed to achieve enduring mental state
Number of CAMS sessions needed to achieve enduring mental state
Time frame
Up to 3 months post-discharge2
Change of Beck Scale for Suicide Ideation score will be analyzed
Change of Beck Scale for Suicide Ideation (SSI) score will be analyzed. SSI scores can range from 0 to 38, and a higher score indicates increased severity of suicidal ideation.
Time frame
Up to 3 months post-dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov