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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, week 2, week 3, week 6, week 8, and week 10

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)

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

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.

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