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

NCT06854367 | Recruiting

• 1 other identifier: CTO4933
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

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

Keywords

Brain stimulation; rTMS; Theta burst stimulation; Accelerated theta burst stimulation

Outcome Measures

Primary Outcomes (1)

• Depression severity

  Montgomery Asberg Depression Rating Scale (MADRS) Change

  6 weeks

Secondary Outcomes (12)

• Depression severity

  up to 10 weeks

• Depression severity

  up to 10 weeks

• Anxiety severity

  up to 10 weeks

• Suicidal ideation

  up to 10 weeks

• Global cognition

  up to 10 weeks

Study Arms (2)

Accelerated TBS

ACTIVE COMPARATOR

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

Device: TBS

Conventional TBS

ACTIVE COMPARATOR

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

Device: TBS

Interventions

TBS DEVICE

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.

Accelerated TBS; Conventional TBS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are voluntary and competent to consent to treatment
• are an outpatient
• are ≥ 60 years old
• have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of MDD, with a current MDE
• 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
• have a score ≥ 10 on the Patient Health Questionnaire (PHQ-9)
• have had no increase or initiation of any antidepressant or antipsychotic medication in the 4 weeks prior to screening
• are able to adhere to the treatment schedule
• pass the TMS adult safety screening (TASS) questionnaire

You may not qualify if:

• have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of substance dependence or abuse within the last 3 months
• have a concomitant major unstable medical illness as determined by one of the study physicians
• have active suicidal intent
• have presumed or probable dementia or clinical evidence of dementia as assessed by Short Blessed Test score ≥ 10
• have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
• have current psychotic symptoms
• 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
• have a diagnosis of any personality disorder as assessed by a study investigator to be primary and causing greater impairment than MDD
• did not respond to a course of ECT in the current depressive episode
• have received rTMS in the current episode; patients who have had rTMS in a previous episode would be eligible
• have a history of a primary seizure disorder or a seizure associated with an intracranial lesion
• 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
• have an implanted electronic device that is currently in function such as a defibrillator
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
• have clinically significant laboratory abnormality, in the opinion of a study investigator

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Centre for Addiction and Mental Healh

Toronto, Ontario, M6J 1H1, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Mood Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 3, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2025-02

Locations

CA (2)