NCT06034821

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).

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
55mo left

Started Oct 2023

Longer than P75 for phase_4

Geographic Reach
2 countries

10 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Oct 2023Dec 2030

First Submitted

Initial submission to the registry

August 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

7 years

First QC Date

August 30, 2023

Last Update Submit

December 8, 2025

Conditions

Acute Suicidal Depression (ASD)

Outcome Measures

Primary Outcomes (1)

  • Scale for Suicidal Ideation (SSI)

    The Scale for Suicidal Ideation (SSI is excellent in terms of test construction and psychometrics (validity and reliability). It has been shown that a SSI score \>6 has been found to be predictive of suicide within 6 months of discharge from hospital. At the end of treatment, patients will be assessed for remission of suicidality which is defined as a SSI score \<4 i.e. no clinically significant suicidal ideation70. A stringent criterion for remission was chosen as ASD is a life-threatening illness and full remission should be the treatment goal.

    Six weeks

Secondary Outcomes (22)

  • Quick Inventory of Depressive Symptoms Self Report QIDS-SR

    Six weeks

  • Columbia Suicide Severity Rating Scale (CSSR-S)

    6 weeks

  • Montgomery Asberg Depression Rating Scale (MADRS)

    6 weeks

  • Working Alliance Inventory (WAI-SR)

    6 weeks

  • National Alcohol and Drug Institute (NIDA) Questionnaire

    6 weeks

  • +17 more secondary outcomes

Study Arms (2)

Subanesthetic dose intravenous ketamine (KET)

ACTIVE COMPARATOR

This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant.

Drug: Subanesthetic dose intravenous ketamine (KET)

Electroconvulsive therapy (ECT)

ACTIVE COMPARATOR

ECT will be given in a standard manner 3 times a week for 4 weeks.

Device: Electroconvulsive therapy (ECT)

Interventions

Electroconvulsive therapy (ECT)DEVICE

ECT will be given in a standard manner 3 times a week for 4 weeks. The Initial ECT treatment will be Right Unilateral (RUL) ultra-brief pulse at 6x seizure threshold determined during titration at first visit. If there is not satisfactory improvement with RUL the investigator may change to Bilateral (BL) utilizing brief pulse using 0.5 modified half-age method to determine stimulus intensity. The seizure threshold may increase during the course of treatment and the dose of the electric stimulus may need to be increased incrementally. It is suggested to change to bilateral after three to five RUL treatments if response to treatment is not satisfactory. Treatments will be given three times a week for up to 4 weeks.

Electroconvulsive therapy (ECT)
Subanesthetic dose intravenous ketamine (KET)DRUG

This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant. Treatments will be given two times a week for a maximum of 8 treatments during the acute arm of the study. The investigators will be able to modify dose and number of treatments as indicated clinically per pragmatic clinical trials procedures. Patients will be clinically assessed prior to each treatment to evaluate response and appropriateness of continuation of treatment. Per FDA guidelines a maximum 60mg/dose will be given regardless of body weight.

Subanesthetic dose intravenous ketamine (KET)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

UC San Francisco

San Francisco, California, 94143, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

UTHealth Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Center for Addiction and Mental Health (University of Toronto)

Toronto, Ontario, M6J 1H4, Canada

Location

Study Officials

  • Amit Anand, MD

    Brigham and Woman's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 13, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(9)