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Procedure
Transcranial Magnetic Stimulation for Depression (ReDeeMD Trial)
N/A
Recruiting
Led By Jean-Philippe Miron, MD PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
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 baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two TMS techniques in people with Major Depressive Disorder to see which works better. It will also evaluate biomarkers to predict response.
Who is the study for?
This trial is for adults with Major Depressive Disorder who haven't improved after two different antidepressants, are on a stable medication regimen, and have a moderate to severe depression score. It's not for those who've had TMS before, have bipolar/psychosis or primary anxiety disorders, unstable medical conditions, recent substance abuse, certain implants, significant lab abnormalities or are pregnant.
What is being tested?
The study compares repetitive TMS (rTMS) and deep TMS (dTMS) in treating treatment-resistant depression. Participants will be randomly assigned to one of these two techniques to see if dTMS is more effective than rTMS and to test the use of biomarkers in predicting outcomes.
What are the potential side effects?
Common side effects of both rTMS and dTMS can include discomfort at the stimulation site during treatment sessions, headache following treatment, lightheadedness or tingling sensations. Rarely seizures may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 6, week 7, week 10, week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 6, week 7, week 10, week 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hamilton Rating Scale for Depression-17 (HRSD-17)
Secondary study objectives
Adult AHDH Self-Report Scale
Cognitive Difficulties Scale (MacNair-R)
Columbia-Suicide Severity Rating Scale (C-SSRS)
+14 moreOther study objectives
Electrocardiogram
Electroencephalogram event-related potentials
Electroencephalogram to predict treatment response
+1 moreAwards & Highlights
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: deep Transcranial Magnetic StimulationExperimental Treatment1 Intervention
dTMS on a research Brainsway system equipped with an H7-Coil. Participants will receive the MDD FDA-cleared 18 Hz stimulation protocol (2 sec ON, 20 sec OFF, 55 trains; 1980 pulses per session; 20 min 10 s duration; 120% hand motor threshold)
Group II: repetitive Transcranial Magnetic StimulationActive Control1 Intervention
rTMS on a MagPro X100 research grade stimulator (MagVenture) equipped with a B70 fluid-cooled coil. Participant will receive the MDD FDA-approved iTBS protocol (triplet 50 Hz bursts repeated at 5 Hz, 2 s ON and 8 s OFF; 600 pulses per session; total duration of 3 min 9 s, 120% hand motor threshold)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial magnetic stimulation
2013
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
378 Previous Clinical Trials
131,501 Total Patients Enrolled
2 Trials studying Depression
38 Patients Enrolled for Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,527,416 Total Patients Enrolled
48 Trials studying Depression
3,273,930 Patients Enrolled for Depression
Jean-Philippe Miron, MD PhDPrincipal InvestigatorCentre de Recherche du Centre Hospitalier de l'Université de Montréal