Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication.
Ronald C Kessler, Patricia Berglund, Olga Demler...
https://pubmed.ncbi.nlm.nih.gov/15939837Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID03272698
Electroconvulsive Therapy with Ketamine Anesthesia Versus High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression: A Prospective Randomized Controlled Trial
Led by University of Saskatchewan · Updated on 2025-01-23
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Saskatchewan
Lead Sponsor
R
Royal University Hospital Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Major depressive disorder (MDD) is a common and disabling psychiatric illness affecting a significant portion of the population. This research aims to evaluate whether a high intensity ketamine treatment combined with electroconvulsive therapy (ECT) rescue, called the HIKER approach, can reduce suffering by speeding up remission, cause fewer side effects, reduce the need for ECT, and be preferred by most patients with treatment-resistant depression (TRD). The study compares the HIKER method to standard ECT therapy with ketamine anesthesia (EAST). Participants are randomly assigned to one of two groups. The HIKER group receives daily high intensity ketamine doses (0.50 mg/kg) for eight consecutive weekdays to induce unconsciousness similar to general anesthesia. The EAST group undergoes eight ECT sessions over 2-3 weeks with ketamine anesthesia combined with other medications to ensure safe anesthesia, using either unilateral or bilateral electrode placement. The ECT sessions are delivered by psychiatrists with seizure monitoring following usual medical standards. During the study, participants will be monitored for their response to treatment, including the number of treatments until disease remission, suicidal thoughts, cognitive function via MMSE tests, and satisfaction with treatment. Assessments occur from the start of treatment up to 8 weeks after, including follow-up 30 days after the last treatment. The study also tracks the need for rescue ECT in the ketamine-only group. Safety and side effects are carefully observed throughout the study period, which may last up to four weeks for remission evaluation and eight weeks for follow-up.
CONDITIONS
Brief Title
ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Montgomery Asberg Depression Rating Scale (MADRS) score greater than 20 and planned for ECT therapy
- Clinical diagnosis of treatment-resistant depression defined as failure to respond to at least two standard drug therapies with adequate duration
- Able to provide informed consent
You will not qualify if you...
- Unable to provide informed consent
- American Society of Anesthesiology physical status score of four or greater
- Presence of implanted electronic medical devices such as pacemaker or deep brain stimulator
- Diagnosis of schizoaffective disorder
- Women of child-bearing potential who refuse or test positive on pregnancy screening
- Allergy to any study drugs or their components
- Serious physical conditions contraindicating ECT such as cardiovascular disease, respiratory disease, cerebrovascular disease, intracranial hypertension including glaucoma, or seizures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 weeks or until disease remission after up to 8 treatments
Participants receive either daily ketamine infusions for 8 successive weekdays or ECT sessions with ketamine anesthesia on a bi/triweekly schedule.
8 treatment visits over up to 4 weeks
Follow-up
Duration - Up to 30 days after last treatment
Participants are monitored for cognitive function, suicidal ideation, and treatment satisfaction for up to 30 days after the last treatment.
Visits at final treatment and 30 days post-treatment
Trial Site Locations
Total: 1 location
1
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
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Research Team
U
Una Goncin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.
Irving Kirsch, Brett J Deacon, Tania B Huedo-Medina...
https://pubmed.ncbi.nlm.nih.gov/18303940Adaptation of N-methyl-D-aspartate (NMDA) receptors following antidepressant treatment: implications for the pharmacotherapy of depression.
P Skolnick, R T Layer, P Popik...
https://pubmed.ncbi.nlm.nih.gov/8852530Definition, assessment, and staging of treatment-resistant refractory major depression: a review of current concepts and methods.
Marcelo T Berlim, Gustavo Turecki
https://pubmed.ncbi.nlm.nih.gov/17444078Is Catatonia a Primary Indication for ECT?
Max Fink
https://pubmed.ncbi.nlm.nih.gov/11941041Influence of anesthetic drugs and concurrent psychiatric medication on seizure adequacy during electroconvulsive therapy.
Bogata D Bundy, Walter Hewer, Franz-Josef Andres...
https://pubmed.ncbi.nlm.nih.gov/20051218Side effects of electroconvulsive therapy.
C J Datto
https://pubmed.ncbi.nlm.nih.gov/11126187Rapid antidepressant effects of repeated doses of ketamine compared with electroconvulsive therapy in hospitalized patients with major depressive disorder.
Mehdi Ghasemi, Mohammad H Kazemi, Abolghasem Yoosefi...
https://pubmed.ncbi.nlm.nih.gov/24374115Methohexital as alternative to propofol for intravenous anesthesia in children undergoing daily radiation treatment: a case report.
K Metriyakool
https://pubmed.ncbi.nlm.nih.gov/9523828Daily oral ketamine for the treatment of depression and anxiety in patients receiving hospice care: a 28-day open-label proof-of-concept trial.
Scott A Irwin, Alana Iglewicz, Richard A Nelesen...
https://pubmed.ncbi.nlm.nih.gov/23805864