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Device

Theta Burst Stimulation for Depression (CogniTReaD Trial)

N/A
Recruiting
Led By Amer M. Burhan, MBChB, MSc
Research Sponsored by Ontario Shores Centre for Mental Health Sciences
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 week 1, week 2, week 3, week 6, week 8, and week 10
Awards & highlights

Summary

This trial will investigate the effectiveness of a new treatment called accelerated bilateral sequential theta burst stimulation (absTBS) for older adults with treatment-resistant depression. The study will compare absTBS with a fake

Who is the study for?
This trial is for individuals aged 50 or older who have treatment-resistant depression of at least moderate severity. It aims to test if a new therapy, absTBS, can improve mood and cognitive functions in these patients.
What is being tested?
The study compares active accelerated bilateral sequential theta burst stimulation (absTBS), a potential new treatment for depression, with a sham (inactive) treatment to see which is more effective in improving symptoms of depression and cognitive function.
What are the potential side effects?
While the specific side effects are not detailed here, participants will be monitored for any adverse reactions to the treatments. Side effects could range from discomfort at the stimulation site to changes in mood or cognition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 2, week 3, week 6, week 8, and week 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 2, week 3, week 6, week 8, and week 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events (AE)

Trial Design

2Treatment groups
Experimental Treatment
Group I: absTBS-sham treatment sequence armExperimental Treatment1 Intervention
Those assigned to the accelerated bilateral sequential theta burst stimulation (absTBS)-sham arm shall receive the blinded active absTBS treatment at Week 1. At Week 3, they shall receive the blinded sham treatment.
Group II: Sham-absTBS treatment sequence armExperimental Treatment1 Intervention
In the sham-absTBS arm, the blinded sham treatment shall be administered at Week 1. The blinded active absTBS treatment shall be given at Week 3.

Find a Location

Who is running the clinical trial?

Ontario Shores Centre for Mental Health SciencesLead Sponsor
13 Previous Clinical Trials
2,164 Total Patients Enrolled
5 Trials studying Depression
615 Patients Enrolled for Depression
Sunnybrook Health Sciences CentreOTHER
671 Previous Clinical Trials
1,564,581 Total Patients Enrolled
35 Trials studying Depression
9,472 Patients Enrolled for Depression
Amer M. Burhan, MBChB, MScPrincipal InvestigatorOntario Shores Centre for Mental Health Sciences and University of Toronto
~36 spots leftby Mar 2026
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