Major Depressive DisorderTTTNCT05388539
TBS Treatment for Treatment-Resistant Depression
A study testing Theta Burst Stimulation in people with Major Depressive Disorder and Unipolar Depression, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Major Depressive Disorder, Unipolar Depression
- What is being tested?
- Theta Burst Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jun 2022to 1 Apr 2024
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria are: patients with a diagnosis of unipolar major depression confirmed by the MINI interview, between 18 and 59 years of age, with a Hamilton score equal to or greater than 17. In addition, patients must have undergone at least 1 first-line treatment for depression and a maximum of 3 previous unsuccessful treatments.
Who cannot join
- Exclusion criteria are: other mental disorders (bipolar affective disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, personality disorders, substance use disorder, psychotic disorders), history of suicide attempts or severe suicidal ideation in the last 6 months. In addition, patients who have a history of epilepsy, decompensated medical conditions, metallic implants in the skull or previous experience with transcranial magnetic stimulation will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry - University of Sao Paulo
São Paulo, 05403903
About this study
Official title: TBS Treatment for Treatment-Resistant Depression: a Randomized, Sham-Controlled Trial
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a new stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. The protocol will be performed for 15 days, totalizing 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3) and will be performed in a Magventure MagPro R30 device. The investigators will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and will apply the protocol randomly, dividing the patients into an active and placebo group. The research team hypothesized that the active group patients will have greater improvement in symptoms of depression assessed by the 17-item hamilton depression scale over patients of the placebo group. In addition, other scales will be used for secondary outcomes. The researchers also hypothesized that there will be no difference between patients placed in the active or placebo groups in terms of side effects.
Read the detailed description
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. This protocol will be applied to patients for 15 days, totaling 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3 obtained by the Beam method) and will be performed in a Magventure MagPro R30 device.
The stimulation will be delivered at 100% of the motor threshold and will last for 6 minutes. The placebo will consist of a noise generator, which makes the same noise as active stimulation, and a surface electrode placed over the patient's eyebrow, mimicking the tactile sensory effects of TBS. The researchers will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and the protocol will be applied randomly, dividing the patients into an active and placebo group. Inclusion criteria are: patients with a diagnosis of unipolar major depression confirmed by the Mini International Neuropsychiatric Interview (MINI), between 18 and 59 years of age, with a Hamilton score equal to or greater than 17. In addition, patients must have undergone at least 1 first-line treatment for depression and a maximum of 3 previous unsuccessful treatments. Exclusion criteria are: other mental disorders (bipolar affective disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, personality disorders, substance use disorder, psychotic disorders), history of suicide attempts or severe suicidal ideation in the last 6 months. In addition, patients who have a history of epilepsy, decompensated medical conditions, metallic implants in the skull or previous experience with transcranial magnetic stimulation will be excluded.
The investigators hypothesized greater improvement in the symptoms of depression in patients of the active group compared with the placebo group, assessed by the 17-item hamilton depression scale. In addition, other scales for secondary outcomes wil be used, such as the Montgomery-Asberg Depression Scale. The research team also hypothesized that there will be no difference between patients in the different groups in terms of side effects. In the patient selection process, individuals will be evaluated and submitted to questionnaires in consultations by video call with a medical doctor of the research team. During the study, patients will be evaluated weekly and in person, by professionals who are not part of the stimulation application group. The service's waiting room will be organized in a certain way, so that patients do not meet or communicate during the study. After the end of the stimulations, the patients will be followed up for another 2 weeks in order to evaluate the support of the response obtained during the investigation. All data will be stored in a secure database with an external hard drive. All ethical considerations will be discussed with patients and followed during the study. The project has already been approved by the ethics committee of the Hospital of Clinics of the University of Sao Paulo. A pilot study will be conducted to assess the feasibility of the protocol.
- Conditions
- Major Depressive Disorder, Unipolar Depression
- Being tested
- Theta Burst Stimulation, Sham Stimulation
- Keywords
- Unipolar Depression, Major Depressive Disorder, Transcranial Magnetic Stimulation, Neuromodulation, Theta Burst Stimulation, Accelerated Theta Burst Stimulation, Intermittent Theta Burst Stimulation
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta Burst StimulationProcedure or surgery
Also called Transcranial Magnetic Stimulation, Magventure - MagPro R30
3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. This protocol will be applied to patients for 15 days, totaling 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3 obtained by the Beam method) and will be performed in a Magventure MagPro R30 device.The stimulation will be delivered at 100% of the motor threshold and will last for 6 minutes.
Sham StimulationProcedure or surgery
Also called Placebo/Sham Stimulation
The placebo will consist of a sham stimulation activity. A noise generator, which makes the same noise as active stimulation, and a surface electrode placed over the patient's eyebrow, mimicking the tactile sensory effects of TBS. It will also occur three times a day, with a duration of 6 minutes. The interval time between procedures will be of 30 minutes. It will take place for the same 15 weekdays, totalizing 45 sham stimulations.
| Study group | Role | What they receive |
|---|---|---|
| Active Group - protocol of Theta Burst Stimulation | Active comparator | 3 sessions of theta burst stimulation, 1200 pulses per session of 6 minutes duration, 30-minute interval between sessions. Stimulation directed to the left dorsolateral pre-frontal cortex. The protocol will be applied for 15 days, totalizing 45 sessions of stimulation. Receives: Procedure: Theta Burst Stimulation |
| Placebo Group - Sham Stimulation | Placebo comparator | The placebo will consist of a sham stimulation activity. A noise generator, which makes the same noise as active stimulation, and a surface electrode placed over the patient's eyebrow, mimicking the tactile sensory effects of TBS. Receives: Procedure: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (17 Items)
Scale to assess depressive symptoms - The minimum scale score is 0 and the maximum scale score is 50 points. The standardized scores are: 7 to 17 points - mild depression; 18 to 25 points - moderate depression and 26 or more points - severe depression. Higher scores mean worse clinical condition or outcome.
Measured: 5 weeks
Secondary outcomes (2)
Montgomery-Asberg Depression Rating Scale
Scale to assess depressive symptoms The minimum scale score is 0 and the maximum scale score is 60 points. The standardized scores are: 7 to 19 points - mild depression; 20 to 34 points - moderate depression and 35 or more points - severe depression. Higher scores mean worse clinical condition or outcome.
Measured: 5 weeks
Collateral Effects Rating Scale
Scale to assess side effects of the procedure - not a numeric scale. It consist of a scale to assess the severity of side effects between: absent, mild, moderate and severe. In addition, the investigators seek to correlate the possible side effect with the procedure in the face of the following alternatives: remotely related, possibly related, probably related, certainly related. For this, the patient's own report, will be taken into account.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start6 Jun 2022
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre R Brunoni, University of Sao Paulo
- Investigators
- Andre R Brunoni, MD, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388539
- Sponsor's protocol ID
- 52384921.6.0000.0068
- Acronym
- TTT
- Status last verified
- Apr 2024
- First submitted
- 13 May 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data can only be accessed by study members. Such data will be stored in a database with an external hard drive (HD). The only way to access this database is to be affiliated with the institution where the study will be conducted and to request authorization from the study director, who coordinates access for the other researchers. During the study, each participant will be evaluated by a single professional and this professional from the research group will be the only one with conditions to add or change clinical data according to evaluation. After data analysis and the end of the research, supplementary materials containing a database preserving the anonymity of the participants will be made available.
Publications
Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
PubMed 17074942Carvalho AF, Sharma MS, Brunoni AR, Vieta E, Fava GA. The Safety, Tolerability and Risks Associated with the Use of Newer Generation Antidepressant Drugs: A Critical Review of the Literature. Psychother Psychosom. 2016;85(5):270-88. doi: 10.1159/000447034. Epub 2016 Aug 11.
PubMed 27508501Meyer JP, Swetter SK, Kellner CH. Electroconvulsive Therapy in Geriatric Psychiatry: A Selective Review. Psychiatr Clin North Am. 2018 Mar;41(1):79-93. doi: 10.1016/j.psc.2017.10.007. Epub 2017 Dec 13.
PubMed 29412850Wischnewski M, Schutter DJ. Efficacy and Time Course of Theta Burst Stimulation in Healthy Humans. Brain Stimul. 2015 Jul-Aug;8(4):685-92. doi: 10.1016/j.brs.2015.03.004. Epub 2015 Mar 26.
PubMed 26014214McClintock SM, Reti IM, Carpenter LL, McDonald WM, Dubin M, Taylor SF, Cook IA, O'Reardon J, Husain MM, Wall C, Krystal AD, Sampson SM, Morales O, Nelson BG, Latoussakis V, George MS, Lisanby SH; National Network of Depression Centers rTMS Task Group; American Psychiatric Association Council on Research Task Force on Novel Biomarkers and Treatments. Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. J Clin Psychiatry. 2018 Jan/Feb;79(1):16cs10905. doi: 10.4088/JCP.16cs10905.
PubMed 28541649Berlim MT, McGirr A, Rodrigues Dos Santos N, Tremblay S, Martins R. Efficacy of theta burst stimulation (TBS) for major depression: An exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res. 2017 Jul;90:102-109. doi: 10.1016/j.jpsychires.2017.02.015. Epub 2017 Feb 21.
PubMed 28254709Brunoni AR, Chaimani A, Moffa AH, Razza LB, Gattaz WF, Daskalakis ZJ, Carvalho AF. Repetitive Transcranial Magnetic Stimulation for the Acute Treatment of Major Depressive Episodes: A Systematic Review With Network Meta-analysis. JAMA Psychiatry. 2017 Feb 1;74(2):143-152. doi: 10.1001/jamapsychiatry.2016.3644.
PubMed 28030740Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
PubMed 29726344Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
PubMed 32252538Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.
PubMed 28657871Sampaio-Junior B, Tortella G, Borrione L, Moffa AH, Machado-Vieira R, Cretaz E, Fernandes da Silva A, Fraguas R, Aparicio LV, Klein I, Lafer B, Goerigk S, Bensenor IM, Lotufo PA, Gattaz WF, Brunoni AR. Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):158-166. doi: 10.1001/jamapsychiatry.2017.4040.
PubMed 29282470Tavares DF, Suen P, Rodrigues Dos Santos CG, Moreno DH, Lane Valiengo LDC, Klein I, Borrione L, Marques Forte P, Brunoni AR, Alberto Moreno R. Treatment of mixed depression with theta-burst stimulation (TBS): results from a double-blind, randomized, sham-controlled clinical trial. Neuropsychopharmacology. 2021 Dec;46(13):2257-2265. doi: 10.1038/s41386-021-01080-9. Epub 2021 Jun 30.
PubMed 34193961Silva RMFD, Brunoni AR, Goerigk S, Batistuzzo MC, Costa DLDC, Diniz JB, Padberg F, D'Urso G, Miguel EC, Shavitt RG. Efficacy and safety of transcranial direct current stimulation as an add-on treatment for obsessive-compulsive disorder: a randomized, sham-controlled trial. Neuropsychopharmacology. 2021 Apr;46(5):1028-1034. doi: 10.1038/s41386-020-00928-w. Epub 2021 Jan 15.
PubMed 33452434Valiengo LDCL, Goerigk S, Gordon PC, Padberg F, Serpa MH, Koebe S, Santos LAD, Lovera RAM, Carvalho JB, van de Bilt M, Lacerda ALT, Elkis H, Gattaz WF, Brunoni AR. Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):121-129. doi: 10.1001/jamapsychiatry.2019.3199.
PubMed 31617873Beam W, Borckardt JJ, Reeves ST, George MS. An efficient and accurate new method for locating the F3 position for prefrontal TMS applications. Brain Stimul. 2009 Jan;2(1):50-4. doi: 10.1016/j.brs.2008.09.006.
PubMed 20539835
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBS Treatment for Treatment-Resistant Depression: a Randomized, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT05388539
- Acronym / sponsor ID
- TTT / 52384921.6.0000.0068
- Conditions
- Major Depressive Disorder, Unipolar Depression
- Keywords
- Unipolar Depression, Major Depressive Disorder, Transcranial Magnetic Stimulation, Neuromodulation, Theta Burst Stimulation, Accelerated Theta Burst Stimulation, Intermittent Theta Burst Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 24 May 2022 (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.
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a new stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. The protocol will be performed for 15 days, totalizing 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3) and will be performed in a Magventure MagPro R30 device. The investigators will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and will apply the protocol randomly, dividing the patients into an active and placebo group. The research team hypothesized that the active group patients will have greater improvement in symptoms of depression assessed by the 17-item hamilton depression scale over patients of the placebo group. In addition, other scales will be used for secondary outcomes. The researchers also hypothesized that there will be no difference between patients placed in the active or placebo groups in terms of side effects.
Detailed description
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. This protocol will be applied to patients for 15 days, totaling 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3 obtained by the Beam method) and will be performed in a Magventure MagPro R30 device.
The stimulation will be delivered at 100% of the motor threshold and will last for 6 minutes. The placebo will consist of a noise generator, which makes the same noise as active stimulation, and a surface electrode placed over the patient's eyebrow, mimicking the tactile sensory effects of TBS. The researchers will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and the protocol will be applied randomly, dividing the patients into an active and placebo group. Inclusion criteria are: patients with a diagnosis of unipolar major depression confirmed by the Mini International Neuropsychiatric Interview (MINI), between 18 and 59 years of age, with a Hamilton score equal to or greater than 17. In addition, patients must have undergone at least 1 first-line treatment for depression and a maximum of 3 previous unsuccessful treatments. Exclusion criteria are: other mental disorders (bipolar affective disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, personality disorders, substance use disorder, psychotic disorders), history of suicide attempts or severe suicidal ideation in the last 6 months. In addition, patients who have a history of epilepsy, decompensated medical conditions, metallic implants in the skull or previous experience with transcranial magnetic stimulation will be excluded.
The investigators hypothesized greater improvement in the symptoms of depression in patients of the active group compared with the placebo group, assessed by the 17-item hamilton depression scale. In addition, other scales for secondary outcomes wil be used, such as the Montgomery-Asberg Depression Scale. The research team also hypothesized that there will be no difference between patients in the different groups in terms of side effects. In the patient selection process, individuals will be evaluated and submitted to questionnaires in consultations by video call with a medical doctor of the research team. During the study, patients will be evaluated weekly and in person, by professionals who are not part of the stimulation application group. The service's waiting room will be organized in a certain way, so that patients do not meet or communicate during the study. After the end of the stimulations, the patients will be followed up for another 2 weeks in order to evaluate the support of the response obtained during the investigation. All data will be stored in a secure database with an external hard drive. All ethical considerations will be discussed with patients and followed during the study. The project has already been approved by the ethics committee of the Hospital of Clinics of the University of Sao Paulo. A pilot study will be conducted to assess the feasibility of the protocol.
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 Group - protocol of Theta Burst Stimulation | Active comparator | Procedure: Theta Burst Stimulation3 sessions of theta burst stimulation, 1200 pulses per session of 6 minutes duration, 30-minute interval between sessions. Stimulation directed to the left dorsolateral pre-frontal cortex. The protocol will be applied for 15 days, totalizing 45 sessions of stimulation. |
| Placebo Group - Sham Stimulation | Placebo comparator | Procedure: Sham StimulationThe placebo will consist of a sham stimulation activity. A noise generator, which makes the same noise as active stimulation, and a surface electrode placed over the patient's eyebrow, mimicking the tactile sensory effects of TBS. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria are: patients with a diagnosis of unipolar major depression confirmed by the MINI interview, between 18 and 59 years of age, with a Hamilton score equal to or greater than 17. In addition, patients must have undergone at least 1 first-line treatment for depression and a maximum of 3 previous unsuccessful treatments.
Key exclusion criteria (1 listed)
- Exclusion criteria are: other mental disorders (bipolar affective disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, personality disorders, substance use disorder, psychotic disorders), history of suicide attempts or severe suicidal ideation in the last 6 months. In addition, patients who have a history of epilepsy, decompensated medical conditions, metallic implants in the skull or previous experience with transcranial magnetic stimulation will be excluded.
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 |
|---|---|---|
| Theta Burst StimulationAlso: Transcranial Magnetic Stimulation, Magventure - MagPro R303 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. This protocol will be applied to patients for 15 days, totaling 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3 obtained by the Beam method) and will be performed in a Magventure MagPro R30 device.The stimulation will be delivered at 100% of the motor threshold and will last for 6 minutes. | Procedure or surgery | Active Group - protocol of Theta Burst Stimulation |
| Sham StimulationAlso: Placebo/Sham StimulationThe placebo will consist of a sham stimulation activity. A noise generator, which makes the same noise as active stimulation, and a surface electrode placed over the patient's eyebrow, mimicking the tactile sensory effects of TBS. It will also occur three times a day, with a duration of 6 minutes. The interval time between procedures will be of 30 minutes. It will take place for the same 15 weekdays, totalizing 45 sham stimulations. | Procedure or surgery | Placebo Group - Sham Stimulation |
Primary outcome
Hamilton Depression Rating Scale (17 Items)
Time frame: 5 weeks
Scale to assess depressive symptoms - The minimum scale score is 0 and the maximum scale score is 50 points. The standardized scores are: 7 to 17 points - mild depression; 18 to 25 points - moderate depression and 26 or more points - severe depression. Higher scores mean worse clinical condition or outcome.
2 secondary outcomes
Montgomery-Asberg Depression Rating Scale
Time frame: 5 weeks
Collateral Effects Rating Scale
Time frame: 5 weeks
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 3 Apr 2024.
- Background: PubMed 17074942Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
- Background: PubMed 27508501Carvalho AF, Sharma MS, Brunoni AR, Vieta E, Fava GA. The Safety, Tolerability and Risks Associated with the Use of Newer Generation Antidepressant Drugs: A Critical Review of the Literature. Psychother Psychosom. 2016;85(5):270-88. doi: 10.1159/000447034. Epub 2016 Aug 11.
- Background: PubMed 29412850Meyer JP, Swetter SK, Kellner CH. Electroconvulsive Therapy in Geriatric Psychiatry: A Selective Review. Psychiatr Clin North Am. 2018 Mar;41(1):79-93. doi: 10.1016/j.psc.2017.10.007. Epub 2017 Dec 13.
- Background: PubMed 26014214Wischnewski M, Schutter DJ. Efficacy and Time Course of Theta Burst Stimulation in Healthy Humans. Brain Stimul. 2015 Jul-Aug;8(4):685-92. doi: 10.1016/j.brs.2015.03.004. Epub 2015 Mar 26.
- Background: PubMed 28541649McClintock SM, Reti IM, Carpenter LL, McDonald WM, Dubin M, Taylor SF, Cook IA, O'Reardon J, Husain MM, Wall C, Krystal AD, Sampson SM, Morales O, Nelson BG, Latoussakis V, George MS, Lisanby SH; National Network of Depression Centers rTMS Task Group; American Psychiatric Association Council on Research Task Force on Novel Biomarkers and Treatments. Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. J Clin Psychiatry. 2018 Jan/Feb;79(1):16cs10905. doi: 10.4088/JCP.16cs10905.
- Background: PubMed 28254709Berlim MT, McGirr A, Rodrigues Dos Santos N, Tremblay S, Martins R. Efficacy of theta burst stimulation (TBS) for major depression: An exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res. 2017 Jul;90:102-109. doi: 10.1016/j.jpsychires.2017.02.015. Epub 2017 Feb 21.
- Background: PubMed 28030740Brunoni AR, Chaimani A, Moffa AH, Razza LB, Gattaz WF, Daskalakis ZJ, Carvalho AF. Repetitive Transcranial Magnetic Stimulation for the Acute Treatment of Major Depressive Episodes: A Systematic Review With Network Meta-analysis. JAMA Psychiatry. 2017 Feb 1;74(2):143-152. doi: 10.1001/jamapsychiatry.2016.3644.
- Background: PubMed 29726344Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
- Background: PubMed 32252538Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
- Background: PubMed 28657871Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.
- Background: PubMed 29282470Sampaio-Junior B, Tortella G, Borrione L, Moffa AH, Machado-Vieira R, Cretaz E, Fernandes da Silva A, Fraguas R, Aparicio LV, Klein I, Lafer B, Goerigk S, Bensenor IM, Lotufo PA, Gattaz WF, Brunoni AR. Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Feb 1;75(2):158-166. doi: 10.1001/jamapsychiatry.2017.4040.
- Background: PubMed 34193961Tavares DF, Suen P, Rodrigues Dos Santos CG, Moreno DH, Lane Valiengo LDC, Klein I, Borrione L, Marques Forte P, Brunoni AR, Alberto Moreno R. Treatment of mixed depression with theta-burst stimulation (TBS): results from a double-blind, randomized, sham-controlled clinical trial. Neuropsychopharmacology. 2021 Dec;46(13):2257-2265. doi: 10.1038/s41386-021-01080-9. Epub 2021 Jun 30.
- Organization World Health, Others. Depression and other common mental disorders: global health estimates. World Health Organization; 2017.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Participant data can only be accessed by study members. Such data will be stored in a database with an external hard drive (HD). The only way to access this database is to be affiliated with the institution where the study will be conducted and to request authorization from the study director, who coordinates access for the other researchers. During the study, each participant will be evaluated by a single professional and this professional from the research group will be the only one with conditions to add or change clinical data according to evaluation. After data analysis and the end of the research, supplementary materials containing a database preserving the anonymity of the participants will be made available.
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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.
Andre R Brunoni, MD, PhD study director
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 Theta Burst Stimulation in people with Major Depressive Disorder and Unipolar Depression, 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 1 inclusion and 1 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 3 Apr 2024. 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?
Hamilton Depression Rating Scale (17 Items) (time frame: 5 weeks). 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 NCT05388539, which also lists 20 linked publications.
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 3 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.