Major Depressive DisorderPDM-TMSNCT05441969
In Vivo Cortical Excitability Modulation in Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Fundacao Champalimaud at 1 site in Portugal.
Trial summary
The pathophysiology of Major Depression Disorder (MDD) is unclear, with several theories for its neurobiological mechanisms. One possible explanation is the presence of altered neuroplasticity, which can be studied by Transcranial Magnetic Stimulation (TMS). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 19 May 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants in this study will be adults, aged 18 to 65 years, that will be recruited either for the clinical groups or healthy subjects group. The clinical population will include individuals with MDE diagnosis, and will be divided into two clinical groups: 1. Patients in the acute phase of MDE, at the time they start a new antidepressant treatment (n≈30); 2. Patients with symptomatic improvement, on continuation or maintenance antidepressant treatment (n≈30). All groups, including healthy subjects, will be paired by age and sex.
Who may be able to join
- 1. Diagnosis of major depressive episode or disorder as provided in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (American Psychiatric Association. 2013).
Who cannot join
- Moderate to severe suicide risk;
- Known personal history of bipolar disorder or psychotic disorder;
- Alcohol or other substance abuse and/or dependence;
- Developmental disorder;
- Dementia;
- Presence of uncontrolled active medical illness;
Show all 14Show fewer
- Known structural lesion of the central nervous system;
- Electrical or metallic brain implants;
- Cardiac implants;
- Epilepsy;
- Active use of medication known to cause seizures;
- Pregnancy;
- Breastfeeding.
- For the healthy control group, participants will also be recruited at the Champalimaud Clinical Center, by advertisement in places of public circulation. The recruitment of this population will be done in order to generate a pairing with both clinical groups in terms of age and sex. The same exclusion criteria will be applied, as well as the presence of any history of neuropsychiatric disease. The total number of participants for this study will be approximately 90 volunteers. Exclusion criteria will be assessed through self-report and/or MINI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Champalimaud Foundation
Lisbon, 1400-038
Sofia Marques, sofia.marques@research.fchampalimaud.org
Albino J Oliveira-Maia, MD, MPH, PhD
About this study
The pathophysiology of Major Depression Disorder (MDD) is unclear, with several theories for its neurobiological mechanisms. One possible explanation is the presence of altered neuroplasticity, which can be studied by Transcranial Magnetic Stimulation (TMS). Using TMS to study these mechanisms is performed by applying electromagnetic stimuli to the motor cortex, to obtain measures of temporary cortical excitability modulation. It is known that depressed patients with higher cortical modulation are more responsive to a TMS treatment course. However, it is unknown if there are differences in cortical modulation between depressed patients and healthy subjects. Our goal is to answer this question and contribute towards clarification of the neuroplasticity mechanisms underlying MDD. Accordingly, the investigators will access cortical excitability modulation measures in both depressed patients and healthy volunteers and compare their results. The investigators will also re-assess these measures after 6 weeks of antidepressant treatment. Finally, the investigators will study the association between cortical excitability measures and cognitive processes using an innovative cognitive task.
Read the detailed description
Study objectives
The aim of this study is to evaluate differences in the modulation of cortical excitability by a repetitive Transcranial Magnetic Stimulation (rTMS) protocol between patients with Major Depressive Disorder (MDD) and healthy people. The investigators hypothesize that patients with MDD exhibit less modulation of cortical excitability when compared to healthy people.
In order to accomplish this goal the investigators will:
- Compare measures of cortical excitability between patients with MDD and healthy individuals;
- Compare the degree of modulation of cortical excitability in motor cortex after the application of rTMS, between healthy individuals and patients with MDD;
- Study the progression/evolution of these measures in the group of patients with MDD after 6 weeks of antidepressant treatment, while comparing patients that respond to treatment with patients with symptoms resistant to treatment;
- Analyze the relationship between cortical excitability measures and cortical excitability modulation. Study participants will perform a psychophysical task, on a computer game, in order to evaluate certain cognitive processes and understand if there are differences in performance between patients with depression and healthy subjects.
Data Collection
- Clinical assessment: Clinical interview will be performed with help of psychiatric, psychological and cognitive psychometric instruments (self-report questionnaires and structured interviews) to assess the participants' health.
- Behavioural assessment: Participants will perform a psychophysical task in the form of a computer game.
- Neurophysiological evaluation: protocol for assessing excitability and excitability modulation of the motor cortex by EMT and EMTr (ETBi).
Procedures
The participants recruited for the present project will be patients who are already being treated by health professionals at the Champalimaud Clinical Center, as well as healthy individuals, recruited from the nearby community. One cohort will include patients with active/symptomatic MDD and a second cohort will include patients with MDD in remission that are still in treatment. The third cohort will include a control group of healthy individuals. After they are referred to participate in this study, and if consent to participate is collected, they will be assessed to confirm their eligibility and group allocation will be performed. The study participants from all three observational groups will be submitted to (1) full clinical information assessment, (2) will be asked to perform a psychophysical task, i.e. a computer game. Finally, (3) the neurophysiological evaluation protocol will be applied. This neurophysiological evaluation protocol will be performed in two visits separated by at least 48h. This will make it possible to assess cortical excitability measures in both hemispheres independently and safely, allowing the acquisition of interhemispheric asymmetry measures. The order in which the cerebral hemispheres will be assessed will be randomized between participants. The first visit should take no longer than 120 minutes, and the second will last less than 45 minutes. Participants in the study will also be asked to come for a second study visit, to the Champalimaud Clinical Center, approximately 6 weeks after the first visit, the same study protocol will be repeated, in two consecutive sessions with the same procedures.Participants will not be rewarded monetarily; they will be supported for travel to the Clinical Center that may be necessary outside their individual clinical follow-up
- Conditions
- Major Depressive Disorder
- Being tested
- No intervention/expousure
- Keywords
- Major Depressive Disorder, Cortical Excitability Modulation, Transcranial Magnetic Stimulation
- 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.
No intervention/expousureOther
No interventions/expousure since this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Current major depressive episode group | Adult individuals (18-65 yrs) diagnosed with current major depressive episode (MDE), under treatment or medication naif, starting a new antidperessant strategy (n≈30). Receives: Other: No intervention/expousure | |
| Maintenance antidepressant treatment group | Adult individuals (18-65 yrs) previously diagnosed with major depressive episode (MDE) currently remitted under continuation or maintenance antidepressant treatment (n≈30). Receives: Other: No intervention/expousure | |
| Healthy subjects group | Adult individuals (18-65 yrs) without current diagnosis of major neuropsychiatric disorders, inlcluding MDE, hence not under any antidepressant medication. The same exclusion criteria will be applied as in the two clincial groups. Receives: Other: No intervention/expousure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline left cortical excitability modulation
Differences between groups in left cortical excitability modulation at baseline. Left cortical excitability modulation will be computed by assessing motor evoked potentials (MEP) before and after left-sided TMS modulation protocol.
Measured: Baseline
Secondary outcomes (1)
Left cortical excitability modulation changes according to treatment response
Differences between responders and non responders to a new antidepressant treatment of left cortical excitability modulation changes between baseline and after 6 weeks.
Measured: Baseline and after ~6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start19 May 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albino Maia, Fundacao Champalimaud
- Investigators
- Albino J Oliveira-Maia, MD, MPH, PhD, Principal investigator, Champalimaud Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441969
- Sponsor's protocol ID
- PDM-TMS
- Acronym
- PDM-TMS
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Benussi A, Di Lorenzo F, Dell'Era V, Cosseddu M, Alberici A, Caratozzolo S, Cotelli MS, Micheli A, Rozzini L, Depari A, Flammini A, Ponzo V, Martorana A, Caltagirone C, Padovani A, Koch G, Borroni B. Transcranial magnetic stimulation distinguishes Alzheimer disease from frontotemporal dementia. Neurology. 2017 Aug 15;89(7):665-672. doi: 10.1212/WNL.0000000000004232. Epub 2017 Jul 26.
PubMed 28747446Blumberger 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 29726344Chang WH, Fried PJ, Saxena S, Jannati A, Gomes-Osman J, Kim YH, Pascual-Leone A. Optimal number of pulses as outcome measures of neuronavigated transcranial magnetic stimulation. Clin Neurophysiol. 2016 Aug;127(8):2892-2897. doi: 10.1016/j.clinph.2016.04.001. Epub 2016 Apr 12.
PubMed 27156431Chung SW, Hill AT, Rogasch NC, Hoy KE, Fitzgerald PB. Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2016 Apr;63:43-64. doi: 10.1016/j.neubiorev.2016.01.008. Epub 2016 Feb 3.
PubMed 26850210Cincotta M, Giovannelli F, Borgheresi A, Balestrieri F, Toscani L, Zaccara G, Carducci F, Viggiano MP, Rossi S. Optically tracked neuronavigation increases the stability of hand-held focal coil positioning: evidence from "transcranial" magnetic stimulation-induced electrical field measurements. Brain Stimul. 2010 Apr;3(2):119-23. doi: 10.1016/j.brs.2010.01.001. Epub 2010 Jan 29.
PubMed 20633439Concerto C, Lanza G, Cantone M, Pennisi M, Giordano D, Spampinato C, Ricceri R, Pennisi G, Aguglia E, Bella R. Different patterns of cortical excitability in major depression and vascular depression: a transcranial magnetic stimulation study. BMC Psychiatry. 2013 Nov 9;13:300. doi: 10.1186/1471-244X-13-300.
PubMed 24206945Daskalakis ZJ, Farzan F, Barr MS, Maller JJ, Chen R, Fitzgerald PB. Long-interval cortical inhibition from the dorsolateral prefrontal cortex: a TMS-EEG study. Neuropsychopharmacology. 2008 Nov;33(12):2860-9. doi: 10.1038/npp.2008.22. Epub 2008 Mar 5.
PubMed 18322469Fitzgerald, Paul B., and Z. Jeff Daskalakis. Repetitive Transcranial Magnetic Stimulation Treatment for Depressive Disorders: A Practical Guide. Heidelberg: Springer, 2013.
Fried PJ, Jannati A, Davila-Perez P, Pascual-Leone A. Reproducibility of Single-Pulse, Paired-Pulse, and Intermittent Theta-Burst TMS Measures in Healthy Aging, Type-2 Diabetes, and Alzheimer's Disease. Front Aging Neurosci. 2017 Aug 21;9:263. doi: 10.3389/fnagi.2017.00263. eCollection 2017.
PubMed 28871222Goldsworthy MR, Hordacre B, Ridding MC. Minimum number of trials required for within- and between-session reliability of TMS measures of corticospinal excitability. Neuroscience. 2016 Apr 21;320:205-9. doi: 10.1016/j.neuroscience.2016.02.012. Epub 2016 Feb 9.
PubMed 26872998Huang YZ, Rothwell JC. The effect of short-duration bursts of high-frequency, low-intensity transcranial magnetic stimulation on the human motor cortex. Clin Neurophysiol. 2004 May;115(5):1069-75. doi: 10.1016/j.clinph.2003.12.026.
PubMed 15066532Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
PubMed 15664172Jahanshahi M, Ridding MC, Limousin P, Profice P, Fogel W, Dressler D, Fuller R, Brown RG, Brown P, Rothwell JC. Rapid rate transcranial magnetic stimulation--a safety study. Electroencephalogr Clin Neurophysiol. 1997 Dec;105(6):422-9. doi: 10.1016/s0924-980x(97)00057-x.
PubMed 9448643Julkunen P, Saisanen L, Danner N, Niskanen E, Hukkanen T, Mervaala E, Kononen M. Comparison of navigated and non-navigated transcranial magnetic stimulation for motor cortex mapping, motor threshold and motor evoked potentials. Neuroimage. 2009 Feb 1;44(3):790-5. doi: 10.1016/j.neuroimage.2008.09.040. Epub 2008 Oct 11.
PubMed 18976714Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
PubMed 12813115
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Cortical Excitability Modulation in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05441969
- Acronym / sponsor ID
- PDM-TMS / PDM-TMS
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Cortical Excitability Modulation, Transcranial Magnetic Stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jul 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.
The pathophysiology of Major Depression Disorder (MDD) is unclear, with several theories for its neurobiological mechanisms. One possible explanation is the presence of altered neuroplasticity, which can be studied by Transcranial Magnetic Stimulation (TMS). Using TMS to study these mechanisms is performed by applying electromagnetic stimuli to the motor cortex, to obtain measures of temporary cortical excitability modulation. It is known that depressed patients with higher cortical modulation are more responsive to a TMS treatment course. However, it is unknown if there are differences in cortical modulation between depressed patients and healthy subjects. Our goal is to answer this question and contribute towards clarification of the neuroplasticity mechanisms underlying MDD. Accordingly, the investigators will access cortical excitability modulation measures in both depressed patients and healthy volunteers and compare their results. The investigators will also re-assess these measures after 6 weeks of antidepressant treatment. Finally, the investigators will study the association between cortical excitability measures and cognitive processes using an innovative cognitive task.
Detailed description
Study objectives
The aim of this study is to evaluate differences in the modulation of cortical excitability by a repetitive Transcranial Magnetic Stimulation (rTMS) protocol between patients with Major Depressive Disorder (MDD) and healthy people. The investigators hypothesize that patients with MDD exhibit less modulation of cortical excitability when compared to healthy people.
In order to accomplish this goal the investigators will:
- Compare measures of cortical excitability between patients with MDD and healthy individuals;
- Compare the degree of modulation of cortical excitability in motor cortex after the application of rTMS, between healthy individuals and patients with MDD;
- Study the progression/evolution of these measures in the group of patients with MDD after 6 weeks of antidepressant treatment, while comparing patients that respond to treatment with patients with symptoms resistant to treatment;
- Analyze the relationship between cortical excitability measures and cortical excitability modulation. Study participants will perform a psychophysical task, on a computer game, in order to evaluate certain cognitive processes and understand if there are differences in performance between patients with depression and healthy subjects.
Data Collection
- Clinical assessment: Clinical interview will be performed with help of psychiatric, psychological and cognitive psychometric instruments (self-report questionnaires and structured interviews) to assess the participants' health.
- Behavioural assessment: Participants will perform a psychophysical task in the form of a computer game.
- Neurophysiological evaluation: protocol for assessing excitability and excitability modulation of the motor cortex by EMT and EMTr (ETBi).
Procedures
The participants recruited for the present project will be patients who are already being treated by health professionals at the Champalimaud Clinical Center, as well as healthy individuals, recruited from the nearby community. One cohort will include patients with active/symptomatic MDD and a second cohort will include patients with MDD in remission that are still in treatment. The third cohort will include a control group of healthy individuals. After they are referred to participate in this study, and if consent to participate is collected, they will be assessed to confirm their eligibility and group allocation will be performed. The study participants from all three observational groups will be submitted to (1) full clinical information assessment, (2) will be asked to perform a psychophysical task, i.e. a computer game. Finally, (3) the neurophysiological evaluation protocol will be applied. This neurophysiological evaluation protocol will be performed in two visits separated by at least 48h. This will make it possible to assess cortical excitability measures in both hemispheres independently and safely, allowing the acquisition of interhemispheric asymmetry measures. The order in which the cerebral hemispheres will be assessed will be randomized between participants. The first visit should take no longer than 120 minutes, and the second will last less than 45 minutes. Participants in the study will also be asked to come for a second study visit, to the Champalimaud Clinical Center, approximately 6 weeks after the first visit, the same study protocol will be repeated, in two consecutive sessions with the same procedures.Participants will not be rewarded monetarily; they will be supported for travel to the Clinical Center that may be necessary outside their individual clinical follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current major depressive episode group | – | Other: No intervention/expousureAdult individuals (18-65 yrs) diagnosed with current major depressive episode (MDE), under treatment or medication naif, starting a new antidperessant strategy (n≈30). |
| Maintenance antidepressant treatment group | – | Other: No intervention/expousureAdult individuals (18-65 yrs) previously diagnosed with major depressive episode (MDE) currently remitted under continuation or maintenance antidepressant treatment (n≈30). |
| Healthy subjects group | – | Other: No intervention/expousureAdult individuals (18-65 yrs) without current diagnosis of major neuropsychiatric disorders, inlcluding MDE, hence not under any antidepressant medication. The same exclusion criteria will be applied as in the two clincial groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be adults, aged 18 to 65 years, that will be recruited either for the clinical groups or healthy subjects group. The clinical population will include individuals with MDE diagnosis, and will be divided into two clinical groups: 1. Patients in the acute phase of MDE, at the time they start a new antidepressant treatment (n≈30); 2. Patients with symptomatic improvement, on continuation or maintenance antidepressant treatment (n≈30). All groups, including healthy subjects, will be paired by age and sex.
Key inclusion criteria (1 listed)
- 1. Diagnosis of major depressive episode or disorder as provided in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (American Psychiatric Association. 2013).
Key exclusion criteria (14 listed)
- Moderate to severe suicide risk;
- Known personal history of bipolar disorder or psychotic disorder;
- Alcohol or other substance abuse and/or dependence;
- Developmental disorder;
- Dementia;
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 |
|---|---|---|
| No intervention/expousureNo interventions/expousure since this is an observational study. | Other | Current major depressive episode group, Healthy subjects group, Maintenance antidepressant treatment group |
Primary outcome
Baseline left cortical excitability modulation
Time frame: Baseline
Differences between groups in left cortical excitability modulation at baseline. Left cortical excitability modulation will be computed by assessing motor evoked potentials (MEP) before and after left-sided TMS modulation protocol.
1 secondary outcome
Left cortical excitability modulation changes according to treatment response
Time frame: Baseline and after ~6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 28747446Benussi A, Di Lorenzo F, Dell'Era V, Cosseddu M, Alberici A, Caratozzolo S, Cotelli MS, Micheli A, Rozzini L, Depari A, Flammini A, Ponzo V, Martorana A, Caltagirone C, Padovani A, Koch G, Borroni B. Transcranial magnetic stimulation distinguishes Alzheimer disease from frontotemporal dementia. Neurology. 2017 Aug 15;89(7):665-672. doi: 10.1212/WNL.0000000000004232. Epub 2017 Jul 26.
- 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 27156431Chang WH, Fried PJ, Saxena S, Jannati A, Gomes-Osman J, Kim YH, Pascual-Leone A. Optimal number of pulses as outcome measures of neuronavigated transcranial magnetic stimulation. Clin Neurophysiol. 2016 Aug;127(8):2892-2897. doi: 10.1016/j.clinph.2016.04.001. Epub 2016 Apr 12.
- Background: PubMed 26850210Chung SW, Hill AT, Rogasch NC, Hoy KE, Fitzgerald PB. Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2016 Apr;63:43-64. doi: 10.1016/j.neubiorev.2016.01.008. Epub 2016 Feb 3.
- Background: PubMed 20633439Cincotta M, Giovannelli F, Borgheresi A, Balestrieri F, Toscani L, Zaccara G, Carducci F, Viggiano MP, Rossi S. Optically tracked neuronavigation increases the stability of hand-held focal coil positioning: evidence from "transcranial" magnetic stimulation-induced electrical field measurements. Brain Stimul. 2010 Apr;3(2):119-23. doi: 10.1016/j.brs.2010.01.001. Epub 2010 Jan 29.
- Background: PubMed 24206945Concerto C, Lanza G, Cantone M, Pennisi M, Giordano D, Spampinato C, Ricceri R, Pennisi G, Aguglia E, Bella R. Different patterns of cortical excitability in major depression and vascular depression: a transcranial magnetic stimulation study. BMC Psychiatry. 2013 Nov 9;13:300. doi: 10.1186/1471-244X-13-300.
- Background: PubMed 18322469Daskalakis ZJ, Farzan F, Barr MS, Maller JJ, Chen R, Fitzgerald PB. Long-interval cortical inhibition from the dorsolateral prefrontal cortex: a TMS-EEG study. Neuropsychopharmacology. 2008 Nov;33(12):2860-9. doi: 10.1038/npp.2008.22. Epub 2008 Mar 5.
- BackgroundFitzgerald, Paul B., and Z. Jeff Daskalakis. Repetitive Transcranial Magnetic Stimulation Treatment for Depressive Disorders: A Practical Guide. Heidelberg: Springer, 2013.
- Background: PubMed 28871222Fried PJ, Jannati A, Davila-Perez P, Pascual-Leone A. Reproducibility of Single-Pulse, Paired-Pulse, and Intermittent Theta-Burst TMS Measures in Healthy Aging, Type-2 Diabetes, and Alzheimer's Disease. Front Aging Neurosci. 2017 Aug 21;9:263. doi: 10.3389/fnagi.2017.00263. eCollection 2017.
- Background: PubMed 26872998Goldsworthy MR, Hordacre B, Ridding MC. Minimum number of trials required for within- and between-session reliability of TMS measures of corticospinal excitability. Neuroscience. 2016 Apr 21;320:205-9. doi: 10.1016/j.neuroscience.2016.02.012. Epub 2016 Feb 9.
- Background: PubMed 15066532Huang YZ, Rothwell JC. The effect of short-duration bursts of high-frequency, low-intensity transcranial magnetic stimulation on the human motor cortex. Clin Neurophysiol. 2004 May;115(5):1069-75. doi: 10.1016/j.clinph.2003.12.026.
- Background: PubMed 15664172Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Albino J Oliveira-Maia, MD, MPH, PhD principal investigator
Champalimaud Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Fundacao Champalimaud at 1 site in Portugal.
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 14 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: looking for participants now, as of the sponsor's last update on 26 Feb 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 Portugal. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Marques (00351 210480048 ext. 4153, sofia.marques@research.fchampalimaud.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline left cortical excitability modulation (time frame: Baseline). 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 NCT05441969, which also lists 33 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 26 Feb 2025.