Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT06854367

Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression

Led by Centre for Addiction and Mental Health · Updated on 2026-01-28

280

Participants Needed

2

Research Sites

244 weeks

Total Duration

On this page

Sponsors

C

Centre for Addiction and Mental Health

Lead Sponsor

S

Sunnybrook Health Sciences Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this trial is to compare the treatment efficacy (improvement in depressive symptoms) of accelerated TBS protocol (where participants receive multiple TBS treatments daily) to conventional TBS protocol (where participants receive a single TBS treatment daily) in late life depression. In addition, the study also aims to determine if specific patterns of stimulation are more or less effective. To do this, all participants will receive active treatments, but some of the participants in this study will receive accelerated TBS and some will receive once daily TBS.

CONDITIONS

Official Title

Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary and competent to consent to treatment
  • Outpatient status
  • Age 60 years or older
  • Diagnosis of major depressive disorder with current major depressive episode confirmed by MINI 7.0
  • Failed to respond adequately to antidepressants or unable to tolerate two trials of antidepressants
  • Patient Health Questionnaire (PHQ-9) score of 10 or higher
  • No increase or start of antidepressant or antipsychotic medication within 4 weeks before screening
  • Able to follow the treatment schedule
  • Passed the TMS adult safety screening (TASS) questionnaire
Not Eligible

You will not qualify if you...

  • Diagnosis of substance dependence or abuse within the last 3 months confirmed by MINI 7.0
  • Major unstable medical illness
  • Active suicidal intent
  • Presumed or probable dementia or Short Blessed Test score of 10 or higher
  • Lifetime diagnosis of bipolar I or II disorder or primary psychotic disorder
  • Current psychotic symptoms
  • Primary diagnosis of OCD, PTSD (current or within last year), anxiety disorders, or dysthymia causing more impairment than MDD
  • Primary diagnosis of any personality disorder causing more impairment than MDD
  • Nonresponse to electroconvulsive therapy in current depressive episode
  • Received rTMS in the current depressive episode
  • History of primary seizure disorder or seizure related to intracranial lesion
  • Presence of intracranial implants or metal objects near the head that cannot be removed safely
  • Implanted electronic devices like defibrillators
  • Significant sensory impairments preventing cooperation
  • Clinically significant lab abnormalities
  • Use of lorazepam over 2 mg daily or any anticonvulsant
  • Psychotherapy must be stable for at least 3 months prior with no anticipated changes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

2

Centre for Addiction and Mental Healh

Toronto, Ontario, Canada, M6J 1H1

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression | DecenTrialz