By InvitationPhase 4

Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

United States1,500 participantsStarted 2023-10-01

Plain-language 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).

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. 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)

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
✕. Satisfying DSM-V criteria of current Mood Depressive Disorder Episode with Psychotic Features (i.e. delusions of hallucinations)
✕. Severe uncontrolled medical illness

What they're measuring

Scale for Suicidal Ideation (SSI)

Timeframe: Six weeks

Trial details

NCT IDNCT06034821

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-10-01

View on ClinicalTrials.gov More Acute Suicidal Depression (ASD) trials