NCT05441969Recruiting
In Vivo Cortical Excitability Modulation in Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 26 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 28 Jun 2022
- Start date
- 19 May 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fundacao Champalimaud
- Diseases
- Depression
- NCT number
- NCT05441969
What you commit to
- Study type: Observational
- Planned participants: 90
- From 19 May 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Electrical or metallic brain implants;
Other illness
- Known personal history of bipolar disorder or psychotic disorder;
- Developmental disorder;
- Dementia;
- Presence of uncontrolled active medical illness;
- Cardiac implants;
- Epilepsy;
- Active use of medication known to cause seizures;
Age
- 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.
Other
- Moderate to severe suicide risk;
- Alcohol or other substance abuse and/or dependence;
- Known structural lesion of the central nervous system;
- Pregnancy;
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Champalimaud Foundation Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.