Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

• Status: Enrolling by invitation
• Trial end date: 2030-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Baylor College of Medicine; Icahn School of Medicine at Mount Sinai; Johns Hopkins University; The Cleveland Clinic; The University of Texas Health Science Center, Houston; University of Arizona; University of Pittsburgh; University of Toronto; Washington University School of Medicine
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Referred to ECT service as a candidate for ECT treatment as assessed by treating clinician.

• Males/females 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).

• Expressing suicidal intent (thinking or behavior suggesting harming or hurting oneself with intent 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) of ≥23(to rule out baseline significant cognitive impairment)

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 breast feeding

• Psychosis

• Severe uncontrolled medical illness

• Ketamine allergy

• Intellectual disability and unable to provide consent or follow study procedures.