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

Recruiting now · Not applicable

Conditions studied: Late Life Depression (LLD), Depression - Major Depressive Disorder, Depressive Disorder, Treatment-Resistant, Mood Disorders

In brief

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.

Key facts

Study ID

NCT06854367

Run by

Centre for Addiction and Mental Health

People needed

280

Starts

2025-03-27

Expected to finish

2029-12-01

Last updated by the study team

2026-01-28

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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
• currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
• 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

Where it is running

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
• Centre for Addiction and Mental Healh — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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