Major Depressive DisorderMrTEDNCT04842929
Magnetic Randomized Trial in Elderly Depressed
A study testing Transcranial magnetic stimulation in people with Major Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jan 2019to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Disorder;
- Patients older than 60 years
- Hamilton equal or higher than 17
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Depression in the Elderly With Repetitive Transcranial Magnetic Stimulation (rTMS) Using Theta-burst Stimulation (TBS): Randomized, Double-blind, Sham-controlled, Clinical Trial
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.
Read the detailed description
Recurrent transcranial magnetic stimulation (rTMS) is a consolidated procedure for the treatment of depression, with several meta-analyzes demonstrating its efficacy. The theta-burst stimulation (TBS) method is a modification of the usual rTMS protocol. As a new protocol, there are still few studies evaluating its efficacy in treatment of major depression, although a recently published meta-analysis has pointed to benefits of this therapeutic modality. To date, there are no studies published with this method for the treatment of geriatric depression. This study will be a randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of theta-burst rTMS in the treatment of major depressive disorder in the elderly, randomizing 108 subjects to the experimental (TBS) and comparative (sham) groups. The coil will be positioned in the dorsolateral prefrontal cortex, with intermittent TBS (iTBS, stimulatory) mode on the left and continuous TBS (cTBS, inhibitory) on the right. Stimulation protocol consists of 1800 pulses on each brain hemisphere, totaling a ten minutes session. There will be 20 consecutive sessions, one a day, except on weekends and holidays. The cycle of continuous intervention will last approximately four weeks, after which applications with the same technique will be performed at the end of weeks 6, 8 and 12. Clinical outcome measures will be obtained on eight occasions: treatment baseline, and after 1, 2, 4, 6, 8 and 12 weeks of onset. The main clinical outcome will be measured using the Hamilton Depression Scale (HDRS), comparing baseline scores with those obtained after 6 weeks of treatment. As secondary endpoints, we will use the Global Clinical Impression Scale (CGI), the CIRS (Cumulative Illness Rating Scale), the Geriatric Depression Scale (GDS), the intermediate scores obtained on the HDRS scale, the Positive and Negative Affect Scale (PANAS), the Montgomery-Asberg Depression Rating Scale (MADRS), and variations in serum BDNF concentrations; all these evaluation tools have validated versions in Portuguese. As tolerability and safety parameters, the incidence of adverse events and the occurrence of manic/hypomanic symptoms will be evaluated by the Young Mania Scale (YMRS). TBS stimulation will be evaluated in terms of safety, tolerability and effectiveness for the treatment of major depression in the elderly, possibly becoming another therapeutic option useful for patients with poor response or contraindications to the use of antidepressants.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial magnetic stimulation
- Keywords
- major depressive disorder, geriatric depression, repetitive transcranial magnetic stimulation (rTMS), theta-burst stimulation (TBS), elderly
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Active comparator | Active Comparator: Active stimulation with pulses emitted according to intervention description Receives: Device: Transcranial magnetic stimulation |
| Sham Stimulation | Sham comparator | Sham 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. Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hamilton Rating Scale for Depression, 17 items (HDRS-17)
Continuous measure (score changes).
Measured: Weeks 0 and 6
Secondary outcomes (11)
Change in HDRS-17
Continuous measure (score changes).
Measured: Weeks 1, 2, 4, 6, 8, 12
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Continuous measure (score changes).
Measured: Weeks 1, 2, 4, 6, 8, 12
Change in Global Clinical Impression Scale (CGI)
Continuous measure (score changes).
Measured: Weeks 1, 2, 4, 6, 8, 12
Change in Cumulative Illness Rating Scale (CIRS)
Continuous measure (score changes).
Measured: Weeks 1, 2, 4, 6, 8, 12
Change in Geriatric Depression Scale (GDS)
Continuous measure (score changes).
Measured: Weeks 1, 2, 4, 6, 8, 12
Change in Positive and Negative Affect Scale (PANAS)
Continuous measure (score changes).
Measured: Weeks 1, 2, 4, 6, 8, 12
Change in serum BDNF concentrations
Continuous measure (score changes).
Measured: Weeks 0 and 6
Response HDRS 17
Response (≥50% improvement from week 0 to 12)
Measured: Week 12
Remission of HDRS 17
Remission (HDRS-17 ≤ 8)
Measured: Week 12
Young Manic Rating Scale (YMRS)
Serious adverse events include treatment-emergent hypomania/mania (YMRS>8), suicide, psychiatric hospitalization and others life-threatening or incapacitant events
Measured: Weeks 0, 1, 2, 4, 6, 8, 12
Serious adverse events
Serious adverse events include treatment-emergent hypomania/mania (YMRS>8), suicide, psychiatric hospitalization and others life-threatening or incapacitant events
Measured: Up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start16 Jan 2019
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Leandro Valiengo, University of Sao Paulo
- Investigators
- Leandro Valiengo, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842929
- Sponsor's protocol ID
- 2.643.551
- Acronym
- MrTED
- Status last verified
- Sep 2025
- First submitted
- 20 Jan 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36118977
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Depression in the Elderly With Repetitive Transcranial Magnetic Stimulation (rTMS) Using Theta-burst Stimulation (TBS): Randomized, Double-blind, Sham-controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT04842929
- Acronym / sponsor ID
- MrTED / 2.643.551
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, geriatric depression, repetitive transcranial magnetic stimulation (rTMS), theta-burst stimulation (TBS), elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recurrent transcranial magnetic stimulation (rTMS) is a consolidated procedure for the treatment of depression, with several meta-analyzes demonstrating its efficacy. The theta-burst stimulation (TBS) method is a modification of the usual rTMS protocol. As a new protocol, there are still few studies evaluating its efficacy in treatment of major depression, although a recently published meta-analysis has pointed to benefits of this therapeutic modality. To date, there are no studies published with this method for the treatment of geriatric depression. This study will be a randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of theta-burst rTMS in the treatment of major depressive disorder in the elderly, randomizing 108 subjects to the experimental (TBS) and comparative (sham) groups. The coil will be positioned in the dorsolateral prefrontal cortex, with intermittent TBS (iTBS, stimulatory) mode on the left and continuous TBS (cTBS, inhibitory) on the right. Stimulation protocol consists of 1800 pulses on each brain hemisphere, totaling a ten minutes session. There will be 20 consecutive sessions, one a day, except on weekends and holidays. The cycle of continuous intervention will last approximately four weeks, after which applications with the same technique will be performed at the end of weeks 6, 8 and 12. Clinical outcome measures will be obtained on eight occasions: treatment baseline, and after 1, 2, 4, 6, 8 and 12 weeks of onset. The main clinical outcome will be measured using the Hamilton Depression Scale (HDRS), comparing baseline scores with those obtained after 6 weeks of treatment. As secondary endpoints, we will use the Global Clinical Impression Scale (CGI), the CIRS (Cumulative Illness Rating Scale), the Geriatric Depression Scale (GDS), the intermediate scores obtained on the HDRS scale, the Positive and Negative Affect Scale (PANAS), the Montgomery-Asberg Depression Rating Scale (MADRS), and variations in serum BDNF concentrations; all these evaluation tools have validated versions in Portuguese. As tolerability and safety parameters, the incidence of adverse events and the occurrence of manic/hypomanic symptoms will be evaluated by the Young Mania Scale (YMRS). TBS stimulation will be evaluated in terms of safety, tolerability and effectiveness for the treatment of major depression in the elderly, possibly becoming another therapeutic option useful for patients with poor response or contraindications to the use of antidepressants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Active comparator | Device: Transcranial magnetic stimulationActive Comparator: Active stimulation with pulses emitted according to intervention description |
| Sham Stimulation | Sham comparator | Device: Transcranial magnetic stimulationSham 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major Depressive Disorder;
- Patients older than 60 years
- Hamilton equal or higher than 17
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationThe 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. | Device | Active Stimulation, Sham Stimulation |
Primary outcome
Changes in Hamilton Rating Scale for Depression, 17 items (HDRS-17)
Time frame: Weeks 0 and 6
Continuous measure (score changes).
11 secondary outcomes
Change in HDRS-17
Time frame: Weeks 1, 2, 4, 6, 8, 12
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Weeks 1, 2, 4, 6, 8, 12
Change in Global Clinical Impression Scale (CGI)
Time frame: Weeks 1, 2, 4, 6, 8, 12
Change in Cumulative Illness Rating Scale (CIRS)
Time frame: Weeks 1, 2, 4, 6, 8, 12
Change in Geriatric Depression Scale (GDS)
Time frame: Weeks 1, 2, 4, 6, 8, 12
Change in Positive and Negative Affect Scale (PANAS)
Time frame: Weeks 1, 2, 4, 6, 8, 12
Change in serum BDNF concentrations
Time frame: Weeks 0 and 6
Response HDRS 17
Time frame: Week 12
Remission of HDRS 17
Time frame: Week 12
Young Manic Rating Scale (YMRS)
Time frame: Weeks 0, 1, 2, 4, 6, 8, 12
Serious adverse events
Time frame: Up to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Derived from this study: PubMed 36118977Valiengo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leandro Valiengo principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Major Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hamilton Rating Scale for Depression, 17 items (HDRS-17) (time frame: Weeks 0 and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04842929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.