Enrolling by InvitationPhase 4ketamine

Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

Sponsored by Brigham and Women's Hospital

NCT ID
NCT06034821
Target Enrollment
1,500 participants
Start Date
2023-10-01
Est. Completion
2030-12-01

About This Study

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).

Conditions Studied

Acute Suicidal Depression (ASD)

Interventions

  • Subanesthetic dose intravenous ketamine (KET)
  • Electroconvulsive therapy (ECT)

Eligibility

Age:18 Years - 90 Years
Healthy Volunteers:No
View full eligibility criteria
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.

Study Locations (10)

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

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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