In Vivo Cortical Excitability Modulation in Major Depressive Disorder

ConditionMajor Depressive Disorder

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorFundacao Champalimaud

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Moderate to severe suicide risk;

Known personal history of bipolar disorder or psychotic disorder;

Alcohol or other substance abuse and/or dependence;

Developmental disorder;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

No intervention/expousure
Other intervention
No interventions/expousure since this is an observational study.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Current major depressive episode group1 intervention

Group B: Maintenance antidepressant treatment group1 intervention

Group C: Healthy subjects group1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacao Champalimaud

Lead sponsor

Source ClinicalTrials.gov

Apply now