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Enrolling by invitationPhase 4

Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

NCT06034821 · REaKT-SD · Brigham and Women's Hospital

Closed to entry
Status
Not accepting participants
Phase 4
Phase
1,500
Target enrolment
10
Study sites
8 US states

What it is testing

Summary

This study is a randomized open-label single-blind non-inferiority comparative effectiveness study of ECT vs. KET for the treatment of Acute Suicidal Depression (ASD).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Scale for Suicidal Ideation (SSI)

    Measured over Six weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 90 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Considered by a clinician as appropriate for referral to treatment services for rapid reversal of acute suicidal depression. 2. Adults 18 - 90 years of age. 3. Meet DSM-5 criteria for Major Depressive Episode (MDE) as determined by Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0). 4. Acute suicidal ideation or behavior (thinking or behavior 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). \* 5. Continue to express suicidal ideation since referral as evidenced by Scale for Suicidal Ideation (SSI) ≥6)\*\* 6. Meet the following criteria on symptom rating scales at screening: 1. Hamilton Depression Scale (HAM-D 17) \>15 2. Montreal Cognitive Assessment (MoCA) of ≥23(to rule out baseline significant cognitive impairment) Exclusion Criteria: 1. Meeting DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder. 2. Not able to give informed consent to receive ECT or KET treatment. 3. Not able to give informed consent to participate in the study. 4. Meet exclusion criteria for ECT treatment as described in guidelines. 5. Meet exclusion criteria for KET treatment such as: 1. Pregnant or breast feeding 2. Satisfying DSM-V criteria of current Mood Depressive Disorder Episode with Psychotic Features (i.e. delusions of hallucinations) 3. Severe uncontrolled medical illness 4. Ketamine allergy 6. Intellectual disability and unable to provide consent or follow study procedures.

Where

10 study sites

FacilityCityRegionCountry
UC San FranciscoSan FranciscoCaliforniaUnited States
Johns Hopkins UniversityBaltimoreMarylandUnited States
McLean HospitalBelmontMassachusettsUnited States
Massachusetts General HospitalBostonMassachusettsUnited States
Mount Sinai School of MedicineNew YorkNew YorkUnited States
Cleveland ClinicClevelandOhioUnited States
University of PittsburghPittsburghPennsylvaniaUnited States
UTHealth HoustonHoustonTexasUnited States
University of UtahSalt Lake CityUtahUnited States
Center for Addiction and Mental Health (University of Toronto)TorontoOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06034821 on ClinicalTrials.gov →

Last updated in the registry 2025-12-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits