NCT06854367Recruiting
Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 21 Feb 2025
- Start date
- 27 Mar 2025
- Primary completion date
- Nov 2029
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Depression
- NCT number
- NCT06854367
What you commit to
- Study type: Interventional
- Planned participants: 280
- From 27 Mar 2025 to the primary completion date, Nov 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- have a concomitant major unstable medical illness as determined by one of the study physicians
- have received rTMS in the current episode; patients who have had rTMS in a previous episode would be eligible
- 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
- 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
Other illness
- 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 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
- have a history of a primary seizure disorder or a seizure associated with an intracranial lesion
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
Lab values
- have clinically significant laboratory abnormality, in the opinion of a study investigator
Other
- have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of substance dependence or abuse within the last 3 months
- have active suicidal intent
- have current psychotic symptoms
- did not respond to a course of ECT in the current depressive episode
- have an implanted electronic device that is currently in function such as a defibrillator
- currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Healh Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.