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Ketamine Versus Electroconvulsive Therapy in Depression
Phase 3
Waitlist Available
Led By Pierre Blier, MD, PhD
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-4 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
No Placebo-Only Group
Summary
This trial compares intravenous ketamine to electroconvulsive therapy (ECT) for patients with depression who haven't responded to other treatments. Ketamine is given through an IV and works quickly to improve mood. The study aims to show that ketamine works faster, has fewer side effects, and is less costly than ECT. Ketamine has been found to elicit a rapid antidepressant response in repeated doses and may improve neurocognitive functioning.
Eligible Conditions
- Major Depressive Disorder
- Depression, Bipolar Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Montgomery-Asberg Depression Rating Scale
Side effects data
From 2023 Phase 1 & 2 trial • 15 Patients • NCT0491654893%
dissociative symptoms
53%
dizziness
40%
dry mouth
27%
increased appetite
27%
sweating
27%
nausea
7%
decreased energy
7%
emotional indifference
7%
loss of sexual desire
7%
restlessness
7%
difficulty sleeping: too little
7%
headache
7%
tremors
7%
trouble achieving orgasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous Ketamine
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous KetamineExperimental Treatment1 Intervention
Group II: Electroconvulsive TherapyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Ontario Shores Centre for Mental Health SciencesOTHER
13 Previous Clinical Trials
1,895 Total Patients Enrolled
Queen's UniversityOTHER
374 Previous Clinical Trials
124,540 Total Patients Enrolled
University Health Network, TorontoOTHER
1,527 Previous Clinical Trials
503,306 Total Patients Enrolled
University of OttawaLead Sponsor
221 Previous Clinical Trials
269,409 Total Patients Enrolled
McGill UniversityOTHER
412 Previous Clinical Trials
1,018,296 Total Patients Enrolled
Pierre Blier, MD, PhDPrincipal InvestigatorThe Royal's Institute of Mental Health Research
1 Previous Clinical Trials
30 Total Patients Enrolled