Comparative Effectiveness of ECT vs. KETAMINE Over the Lifespan
- Conditions
- Acute Suicidal Depression (ASD)
- Interventions
- Device: Electroconvulsive therapy (ECT)Drug: Subanesthetic dose intravenous ketamine (KET)
- Registration Number
- NCT06034821
- Lead Sponsor
- Brigham and Women's Hospital
- 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 varying efficacy are available for prevention of suicide. However, once acute suicidal depression has set in, its treatment is woefully inadequate in the current health system despite availability of efficacious treatments. Patients suffering from ASD are usually admitted as inpatients for safety and started on oral antidepressants (which can take 6 - 12 weeks to have an effect) and given nursing care. They are then discharged from the hospital, usually within 4 -5 days, as soon as immediate safety concerns are ameliorated. Essentially, patients do not receive any specific rapidly acting treatment for their suicidal depression. As The immediate post-discharge period has been shown to be of the highest risk for repeat suicide attempts and completed suicides. One important reason for the inadequate treatment of ASD is the lack of large-scale comparative studies of efficacious treatments such as electroconvulsive therapy (ECT) and subanesthetic dose intravenous ketamine (KET). In the absence of data to guide rational treatment choice, neither treatment is being used adequately. Clinicians are less likely to recommend these treatments in the absence of evidence to base their decision regarding which treatment to give first and under what circumstances. Patients are reluctant to choose between these treatments due to uncertainty regarding efficacy and apprehension regarding side effects and social stigma. Finally, in the absence of effectiveness data, hospital administrators and third-party payers are reticent about committing material and financial resources for these services leading to inaccessibility. Hence, there is a critical need for a large-scale comparative effectiveness trial of ECT vs. intravenous ketamine for rapid reversal of ASD to provide rational guidance for all stakeholders.
This study will address this significant clinical dilemma by conducting a large scale (N = 1500) non-inferiority randomized comparative effectiveness trial of ECT vs. KET for rapid treatment of acute suicidal major depression (ASD) across the lifespan.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1500
- 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 and Montreal Cognitive Assessment (MoCA) of ≥23(to rule out baseline significant cognitive impairment)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroconvulsive therapy (ECT) Electroconvulsive therapy (ECT) ECT will be given in a standard manner 3 times a week for 4 weeks. Subanesthetic dose intravenous ketamine (KET) Subanesthetic dose intravenous ketamine (KET) 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.
- Primary Outcome Measures
Name Time Method Scale for Suicidal Ideation (SSI) Six weeks 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.
- Secondary Outcome Measures
Name Time Method Quick Inventory of Depressive Symptoms Self Report QIDS-SR Six weeks Self-reported questionnaire
National Alcohol and Drug Institute (NIDA) Questionnaire 6 weeks Substance use questionnaire
Quality of Life Scale (QOLS) 6 weeks Range 16-112, higher scores indicate better outcomes.
Montgomery Asberg Depression Rating Scale (MADRS) 6 weeks Clinician rated scales
MOCA 6 weeks Range 0-30, higher scores indicate better outcomes.
IAT 6 weeks Range scores -2-+2
Suicidal Behavior Questionnaire-Revised (SBQ-R) 6 weeks Range 3-18, higher scores indicate worse outcomes.
Patient-rated global assessment of severity and improvement (PGI-S/PGI-I) 6 weeks Range 1-7, higher scores indicate worse outcomes.
Young Mania Rating Scale (YMRS) 6 weeks Range 0-60, higher scores indicate worse outcomes.
Working Alliance Inventory (WAI-SR) 6 weeks Questionnaire
Brief Psychiatric Rating Scale 4 items (BPRS) 6 weeks 4 items for psychosis, higher scores indicate worse outcomes. Range 4-28.
CGI-S 6 weeks Range 1-7, higher scores indicate worse outcomes.
CGI-I 6 weeks Range 1-7, higher scores indicate worse outcomes.
COWAT (Total words T-score) 6 weeks Range 0-30, higher scores indicate better outcomes.
HVLT-R (Total T-score) 6 weeks Range 0-100, higher scores indicate better outcomes.
Patient Rated Inventory of Side Effects (PRISE) 6 weeks Not scored
Likert Scale Treatment Preference Questionnaire 6 weeks Range 0-7
National Alcohol and Drug Institute (NIDA) substance use questionnaire (TAPS-I and II) 6 weeks Substance specific scores 0-3, higher scores indicate worse outcomes.
Self and clinician rated scales 6 weeks Measuring length of hospital stay, memory, side effects and quality of life
Global Self Evaluation of Memory (GSE-My) 6 weeks Range 1-7, higher scores indicate worse outcomes.
Columbia Suicide Severity Rating Scale (CSSR-S) 6 weeks Clinician rated scales for suicidality and depression
Clinician Administered Dissociative Symptoms Scale (CADSS) 6 weeks Range 0-80, higher scores indicate worse outcomes.
Trial Locations
- Locations (11)
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
UTHealth Houston
🇺🇸Houston, Texas, United States
Center for Addiction and Mental Health (University of Toronto)
🇨🇦Toronto, Ontario, Canada