Clinical TrialSuicidalityKetaminePlaceboEnrolling by invitation

Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan (REaKT-SD)

Randomized, open-label, single-blind, non-inferiority Phase IV comparative effectiveness trial (n=1500) comparing ECT versus subanesthetic IV ketamine (0.5 mg/kg) for rapid treatment of acute suicidal depression.

Target Enrollment
1500 participants
Study Type
Phase IV interventional
Design
Randomized

Detailed Description

This pragmatic, multi-centre trial randomises adults with acute suicidal major depression to standard electroconvulsive therapy or subanesthetic intravenous ketamine to assess non-inferiority for rapid reduction of suicidal ideation and depressive symptoms.

Ketamine is administered as 0.5 mg/kg IV infusions over 40 minutes twice weekly for up to eight treatments (with a per-dose cap of 60 mg); ECT is delivered three times weekly for up to four weeks using RUL ultra-brief pulse with option to convert to bilateral if required.

Primary outcomes focus on rapid change in suicidal ideation and depression severity; pragmatic design permits clinical dose and treatment modifications per protocol and usual-care procedures.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

Subanesthetic IV ketamine 0.5 mg/kg infusion, up to 8 treatments

Interventions

  • Ketamine0.5 mg/kg
    via IV• two times a week• 8 doses total

    0.5 mg/kg infusion over 40 minutes; per FDA guidance max 60 mg/dose

ECT

active comparator

Standard ECT three times weekly for up to 4 weeks (RUL ultra-brief pulse, may convert to bilateral)

Interventions

  • Placebo
    via Other• three times a week• 12 doses total

    Right unilateral ultra-brief pulse at ~6x seizure threshold during titration; may change to bilateral if response unsatisfactory; up to 4 weeks of treatment

Participants

Ages
18 – 90
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Considered by a clinician as appropriate for referral to treatment services for rapid reversal of acute suicidal depression.
  • Adults 18-90 years of age.
  • Meet DSM-5 criteria for Major Depressive Episode (MDE) as determined by Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0).
  • Acute suicidal ideation or behaviour (thinking or behaviour suggesting harming or hurting oneself with knowledge that death may result) or attempt (any intentional, non-fatal self-injury regardless of medical lethality, if intent to die was indicated).
  • Continue to express suicidal ideation since referral as evidenced by Scale for Suicidal Ideation (SSI) ≥6.
  • Meet the following criteria on symptom rating scales at screening: Hamilton Depression Scale (HAM-D 17) >15 and Montreal Cognitive Assessment (MoCA) ≥23 (to rule out baseline significant cognitive impairment).

Exclusion Criteria

  • Exclusion Criteria:
  • Meeting DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder.
  • Not able to give informed consent to receive ECT or KET treatment.
  • Not able to give informed consent to participate in the study.
  • Meet exclusion criteria for ECT treatment as described in guidelines.
  • Meet exclusion criteria for KET treatment such as:
  • * Pregnant or breastfeeding
  • * Satisfying DSM-5 criteria for current mood depressive episode with psychotic features (i.e. delusions or hallucinations)
  • * Severe uncontrolled medical illness
  • * Ketamine allergy
  • * Intellectual disability and unable to provide consent or follow study procedures.

Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment1500 participants
  • Timeline
    Start: 2023-10-01
    End: 2030-03-01
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

UC San Francisco — San Francisco, California, United States
Johns Hopkins University — Baltimore, Maryland, United States
McLean Hospital — Belmont, Massachusetts, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Mount Sinai School of Medicine — New York, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
University of Pittsburgh — Pittsburgh, Pennsylvania, United States
UTHealth Houston — Houston, Texas, United States
University of Utah — Salt Lake City, Utah, United States
Center for Addiction and Mental Health (University of Toronto) — Toronto, Ontario, Canada

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