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
Study Comparing Electroconvulsive Therapy with Ketamine Anesthesia to High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression A Prospective Randomized Controlled Trial by the University of Saskatchewan
Led by University of Saskatchewan · Updated on 2025-01-23
62
Participants Needed
1
Research Sites
434 weeks
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, with treatment-resistant depression (TRD) affecting patients who do not improve after at least two antidepressant therapies. This trial evaluates two treatments for TRD: a high intensity ketamine approach with electroconvulsive therapy (ECT) rescue (HIKER) versus standard ECT with ketamine anesthesia (EAST). The study aims to see if HIKER can speed up remission, reduce side effects and ECT usage, and be preferred by patients. Participants are randomly assigned to one of two groups. The HIKER group receives high intensity intravenous ketamine treatments daily for eight consecutive days, while the EAST group receives eight ECT treatments with ketamine anesthesia, given two or three times per week. If patients in the HIKER group do not respond to ketamine, they may receive ECT as a rescue treatment. During the study, researchers will track the number of treatments needed to reach remission, assessing up to four weeks after randomization or after eight treatments. Participants will undergo depression rating assessments and monitoring for side effects. The trial also observes patient preferences and safety outcomes throughout the study period.
CONDITIONS
Official 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
- Failure to respond to at least 2 standard-of-care drug therapies of adequate duration for treatment-resistant depression
You will not qualify if you...
- Unable to provide informed consent
- American Society of Anesthesiology physical status score of 4 or greater
- Implanted electronic medical device such as pacemaker, defibrillator, intrathecal pump, spinal cord stimulator, or deep brain stimulator
- Diagnosis of schizoaffective disorder
- Women of child-bearing potential who refuse or test positive on pregnancy screening
- Allergy to study drugs or their carrier components
- Serious physical conditions deemed contraindications to ECT including cardiovascular disease (including untreated hypertension), 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
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