An observational study in Major Depressive Disorder, sponsored by Fundacao Champalimaud. Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Fundacao Champalimaud · Observational
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.
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:
Data Collection
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
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 90 is below the median of 150 across 653 observational studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Fundacao Champalimaud is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
All groups, including healthy subjects, will be paired by age and sex.
Exclusion criteria (clinical groups):
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.
Adult individuals (18-65 yrs) diagnosed with current major depressive episode (MDE), under treatment or medication naif, starting a new antidperessant strategy (n≈30).
Other: No intervention/expousure
Adult individuals (18-65 yrs) previously diagnosed with major depressive episode (MDE) currently remitted under continuation or maintenance antidepressant treatment (n≈30).
Other: No intervention/expousure
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.
Other: No intervention/expousure
No interventions/expousure since this is an observational study.
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.
Time frame: Baseline
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.
Time frame: Baseline and after ~6 weeks.
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.
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