Actively Recruiting
Accelerated versus Conventional Theta Burst Stimulation for Treating Late-Life Depression
Led by Centre for Addiction and Mental Health · Updated on 2026-01-28
280
Participants Needed
2
Research Sites
4 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
Researchers are investigating the effectiveness of accelerated versus conventional theta burst stimulation (TBS) for treating moderate to severe late-life depression. This study aims to compare improvements in depressive symptoms by measuring changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores. The research also explores whether specific patterns of brain stimulation lead to better results, with all participants receiving active TBS treatment either in an accelerated or conventional manner. Participants in the accelerated TBS group will receive five treatment sessions daily, spaced about an hour apart, for four consecutive days during the first week and two non-consecutive days in the second week. The conventional TBS group will undergo one treatment session daily for 30 days, typically over six weeks. Each treatment involves either continuous TBS on the right dorsolateral prefrontal cortex followed by intermittent TBS on the left dorsolateral prefrontal cortex or intermittent TBS on the left side alone. During the study, participants will attend treatment sessions and undergo assessments of depression severity at six weeks, with additional monitoring of anxiety, suicidal thoughts, cognitive functions, disability, and quality of life up to ten weeks. Researchers will also evaluate participants' expectations and preferences before treatment. Safety is carefully monitored, and participants must adhere to the treatment schedule for the study duration, which lasts several weeks depending on their assigned group.
CONDITIONS
Brief Title
Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression
Who Can Participate
Eligibility Criteria
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 a current major depressive episode confirmed by Mini International Neuropsychiatric Interview (MINI 7.0)
- Failed clinical response to adequate antidepressant treatment or intolerance to two separate antidepressants
- Patient Health Questionnaire (PHQ-9) score of 10 or higher
- No increase or start of antidepressant or antipsychotic medication in the 4 weeks before screening
- Able to follow the treatment schedule
- Pass the Transcranial Magnetic Stimulation adult safety screening questionnaire
You will not qualify if you...
- Diagnosis of substance dependence or abuse within the last 3 months
- Major unstable medical illness
- Active suicidal intent
- Probable or confirmed dementia (Short Blessed Test score 10 or higher)
- Lifetime diagnosis of bipolar I or II disorder or primary psychotic disorder
- Current psychotic symptoms
- Diagnosis of certain anxiety disorders, PTSD, OCD, or dysthymia causing more impairment than depression
- Primary personality disorder causing greater impairment than depression
- No response to electroconvulsive therapy in current episode
- Prior rTMS treatment in current depressive episode
- History of seizure disorder or seizures related to intracranial lesions
- Intracranial metal implants or nearby metal objects that cannot be removed safely
- Implanted electronic devices like defibrillators
- Significant sensory impairments preventing cooperation
- Clinically significant laboratory abnormalities
- Use of lorazepam over 2 mg daily or any anticonvulsants
- Unstable psychotherapy treatment or anticipated changes in therapy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks depending on treatment group
Participants receive theta burst stimulation (TBS) treatments. The accelerated group receives 5 treatments per day for 4 consecutive days in week 1 and 2 non-consecutive days in week 2. The conventional group receives 1 treatment per day for 30 days over approximately 6 weeks.
Multiple visits per day for up to 6 weeks depending on group assignment
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
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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