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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 6, week 7, week 10, week 18 for reporting.

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 more

Other study objectives

Electrocardiogram

Electroencephalogram event-related potentials

Electroencephalogram to predict treatment response

+1 more

Awards & 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

~760

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