Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

ID#: NCT06034821

Age: 18 - 90 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Enrolling by invitation

Start Date: October 01, 2023

End Date: March 01, 2030

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).

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.