Clinical TrialSuicidalityKetaminePlaceboRecruiting

Ketamine Treatment of Youth Suicide Attempters

This double-blind, placebo-controlled trial (n=140) investigates the efficacy and safety of ketamine in rapidly reducing severe suicide risk among youth aged 14-30 who have attempted suicide.

Target Enrollment
140 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-blind, placebo-controlled parallel trial (n=140) in inpatient youth (14–30) comparing IV ketamine 0.5 mg/kg infused over 40 minutes every other day to saline; up to six infusions until clinical response or discharge.

All participants receive weekly CAMS psychotherapy starting as an inpatient and continuing outpatient; outcomes include SSI scores, suicidal attempts, readmissions and monthly follow-up for 3 months.

Study Protocol

Preparation

sessions

Dosing

6 sessions
40 min each

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Ketamine + CAMS

experimental

IV ketamine infusions plus weekly CAMS psychotherapy

Interventions

  • Ketamine0.5 mg/kg
    via IV• every other day• 6 doses total

    0.5 mg/kg IV infusion over 40 minutes; repeat every other day up to 6 infusions or until response/discharge.

  • Compound
    via Other• weekly

    CAMS weekly psychotherapy starting inpatient and continuing outpatient.

Saline + CAMS

inactive

Saline placebo infusions plus weekly CAMS psychotherapy

Interventions

  • Placebo
    via IV• every other day• 6 doses total

    Saline (0.9% sodium chloride) infusion over 40 minutes as placebo comparator.

  • Compound
    via Other• weekly

    CAMS weekly psychotherapy starting inpatient and continuing outpatient.

Participants

Ages
14 – 30
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Subjects must be 14 to 30 years of age
  • Subjects must have been admitted to Cleveland Clinic Hospital (Fairview, Marymount, or Lutheran Hospital) or Massachusetts General Hospital (Blake 11) 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 clinician 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.

Exclusion Criteria

  • 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.
  • 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)
  • 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 who are currently pregnant and/or breast feeding.
  • Subjects with previous recreational ketamine use. Subjects with previous therapeutic Ketamine use that exceeds the maximum cumulative lifetime exposure of 60 mg daily and 8 administrations maximum (or 480 mg) during both previous treatment and the proposed inclusion of this study.
  • Subjects with hypertension, history of myocardial infarction, congestive heart failure of Stage 2 or higher, angina, or QTcF of at least 450 msec as indicated by chart review and/or standard of care EKG performed upon admission to inpatient unit.
  • Subjects in the custody of Children's Services.

Study Details

  • Status
    Recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment140 participants
  • Timeline
    Start: 2022-06-27
    End: 2024-08-31
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Massachusetts General Hospital — Boston, Massachusetts, United States
The Cleveland Clinic — Cleveland, Ohio, United States

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