Magnetic Randomized Trial in Elderly Depressed
MrTED
Treatment of Depression in the Elderly With Repetitive Transcranial Magnetic Stimulation (rTMS) Using Theta-burst Stimulation (TBS): Randomized, Double-blind, Sham-controlled, Clinical Trial
1 other identifier
interventional
108
1 country
1
Brief Summary
Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited for issues such as refractoriness, adverse effects and drug interactions, especially in the elderly population. In this context, the investigators investigate a non-pharmacological treatment known as recurrent transcranial magnetic stimulation (rTMS) with the theta-burst stimulation (TBS) method for the treatment of geriatric depression. This treatment modality has almost no adverse effects and avoids the risk associated with polypharmacy, providing an interesting alternative to antidepressant treatments. Our aim is to evaluate TBS efficacy in the treatment of geriatric depression in a randomized, double-blind, placebo-controlled clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable major-depressive-disorder
Started Jan 2019
Longer than P75 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 16, 2019
CompletedFirst Submitted
Initial submission to the registry
January 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedSeptember 29, 2025
September 1, 2025
4.2 years
January 20, 2021
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Hamilton Rating Scale for Depression, 17 items (HDRS-17)
Continuous measure (score changes).
Weeks 0 and 6
Secondary Outcomes (11)
Change in HDRS-17
Weeks 1, 2, 4, 6, 8, 12
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Weeks 1, 2, 4, 6, 8, 12
Change in Global Clinical Impression Scale (CGI)
Weeks 1, 2, 4, 6, 8, 12
Change in Cumulative Illness Rating Scale (CIRS)
Weeks 1, 2, 4, 6, 8, 12
Change in Geriatric Depression Scale (GDS)
Weeks 1, 2, 4, 6, 8, 12
- +6 more secondary outcomes
Other Outcomes (2)
Conditioned pain modulation
Week 0 and 4
Actigraphy
1 week before treatment up to 4 weeks after finishing study
Study Arms (2)
Active Stimulation
ACTIVE COMPARATORActive Comparator: Active stimulation with pulses emitted according to intervention description
Sham Stimulation
SHAM COMPARATORSham Comparator: The blinding will be done with a sham coil, which consists of a coil that reproduces the sound that the true coil does, but without generating the magnetic field.
Interventions
The coil will be positioned in the prefrontal dorsolateral cortex, with intermintent TBS (TBSi) mode on the left and continuous TBS (TBSc) on the right. 1800 pulses will be used on each side, totaling 10 minutes of total duration. There will be 20 consecutive sessions, one per day, except on weekends and holidays, totaling around 4 weeks. A day of stimulation with the same technique will be done in the 6th week, 8th week and 12th week.
Eligibility Criteria
You may qualify if:
- Major Depressive Disorder;
- Patients older than 60 years
- Hamilton equal or higher than 17
You may not qualify if:
- Other mental disorders (alcohol or drug addiction, psychotic disorders, dementia, bipolar disorder);
- Presence of serious neurological or clinical diseases;
- Resence of severe suicidal ideation and CIRS (Cumulative Illness Rating Scale) score\> 7, characterizing a set of clinical morbidities that could impair adherence to the research protocol, bipolar disorder and/or presence of manic symptoms (hypo) demonstrated with more than 8 points in the Young Mania Rating Scale.
- Metal implants;
- Epilepsy or electronics in the cephalic segment;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Brain & Behavior Research Foundationcollaborator
Study Sites (1)
University of Sao Paulo
São Paulo, São Paulo, Brazil
Related Publications (1)
Valiengo L, Pinto BS, Marinho KAP, Santos LA, Tort LC, Benatti RG, Teixeira BB, Miranda CS, Cardeal HB, Suen PJC, Loureiro JC, Vaughan RAR, Dini Mattar RAMPF, Lessa M, Oliveira PS, Silva VA, Gattaz WF, Brunoni AR, Forlenza OV. Treatment of depression in the elderly with repetitive transcranial magnetic stimulation using theta-burst stimulation: Study protocol for a randomized, double-blind, controlled trial. Front Hum Neurosci. 2022 Aug 31;16:941981. doi: 10.3389/fnhum.2022.941981. eCollection 2022.
PMID: 36118977DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leandro Valiengo
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 20, 2021
First Posted
April 13, 2021
Study Start
January 16, 2019
Primary Completion
March 20, 2023
Study Completion
March 20, 2023
Last Updated
September 29, 2025
Record last verified: 2025-09