Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

Enrolling by invitation · Phase 4

Conditions studied: Acute Suicidal Depression (ASD)

In brief

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).

Key facts

Study ID

NCT06034821

Run by

Brigham and Women's Hospital

People needed

1500

Starts

2023-10-01

Expected to finish

2030-12-01

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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). *
• 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
• Montreal Cognitive Assessment (MoCA) of ≥23(to rule out baseline significant cognitive impairment)

You may not qualify if…

• 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 breast feeding
• Satisfying DSM-V criteria of current Mood Depressive Disorder Episode with Psychotic Features (i.e. delusions of hallucinations)
• Severe uncontrolled medical illness
• Ketamine allergy
• Intellectual disability and unable to provide consent or follow study procedures.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.