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Status:

ENROLLING_BY_INVITATION

Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan

Lead Sponsor:

Brigham and Women's Hospital

Collaborating Sponsors:

Johns Hopkins University

University of Pittsburgh

Conditions:

Acute Suicidal Depression (ASD)

Eligibility:

All Genders

18-90 years

Phase:

PHASE4

Brief 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).

Detailed Description

There is a crisis in the treatment of the imminently suicidal patient. Acute Suicidal Depression (ASD) is a life-threatening illness which requires rapid relief. A number of behavioral programs with v...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2030

Estimated Enrollment :

1500 Patients enrolled

Trial Details

Trial ID

NCT06034821

Start Date

October 1 2023

End Date

December 1 2030

Last Update

December 15 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

UC San Francisco

San Francisco, California, United States, 94143

2

Johns Hopkins University

Baltimore, Maryland, United States, 21287

3

McLean Hospital

Belmont, Massachusetts, United States, 02478

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114