Recruiting

Accelerated TBS & Conventional TBS

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06854367

Conditions

Late Life Depression (LLD)

Depression - Major Depressive Disorder

Depressive Disorder, Treatment-Resistant

Mood Disorders

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

TBS

Study Details

Brief summary:

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

Late Life Depression (LLD)

Depression - Major Depressive Disorder

Depressive Disorder, Treatment-Resistant

Mood Disorders

Study ID

NCT06854367

Start date

Mar 27, 2025

Status verified date

Feb, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. are voluntary and competent to consent to treatment
2. are an outpatient
3. are ≥ 60 years old
4. have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of MDD, with a current MDE
5. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have failed to tolerate two separate trials of an antidepressant
6. have a score ≥ 10 on the Patient Health Questionnaire (PHQ-9)
7. have had no increase or initiation of any antidepressant or antipsychotic medication in the 4 weeks prior to screening
8. are able to adhere to the treatment schedule
9. pass the TMS adult safety screening (TASS) questionnaire

Exclusion Criteria:

1. have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of substance dependence or abuse within the last 3 months
2. have a concomitant major unstable medical illness as determined by one of the study physicians
3. have active suicidal intent
4. have presumed or probable dementia or clinical evidence of dementia as assessed by Short Blessed Test score ≥ 10
5. have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
6. have current psychotic symptoms
7. have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD
8. have a diagnosis of any personality disorder as assessed by a study investigator to be primary and causing greater impairment than MDD
9. did not respond to a course of ECT in the current depressive episode
10. have received rTMS in the current episode; patients who have had rTMS in a previous episode would be eligible
11. have a history of a primary seizure disorder or a seizure associated with an intracranial lesion
12. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
13. have an implanted electronic device that is currently in function such as a defibrillator
14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
15. have clinically significant laboratory abnormality, in the opinion of a study investigator
16. currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
17. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Accelerated TBS

Multiple treatments a day (5 treatments/day) for 4 consecutive days in the first week and 2 non-consecutive days in the second week.

active comparator: Conventional TBS

Treatment once a day for 30 days (e.g., 5 days a week for 6 weeks)

Interventions

TBS

Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neurostimulation that uses focused magnetic field pulses to directly stimulate cortical neurons. Theta burst stimulation (TBS) is a briefer form of patterned rTMS that has been shown to be effective against major depressive disorder. Each treatment will consist of either 1) cTBS of right DLPFC followed by iTBS of left DLPFC; or 2) iTBS of left DLPFC.

Primary outcome measure

  • Depression severity [ Time Frame: 6 weeks ]

Central Contacts and Locations

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Sean M Nestor

Centre for Addiction and Mental Healh

Recruiting

Toronto, Ontario, Canada, M6J 1H1

Contacts

Principal Investigator:

Hyewon (Helen) Lee

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Jan 28, 2026

Last verified

Feb, 2025

Keywords

  • Brain stimulation
  • rTMS
  • Theta burst stimulation
  • Accelerated theta burst stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-01-28.