Examining brain activity differences in depression
In Vivo Cortical Excitability Modulation in Major Depressive Disorder
Fundacao Champalimaud · NCT05441969
This study is testing how brain activity differs between people with Major Depressive Disorder and healthy individuals to see if brain stimulation and antidepressants can change those differences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fundacao Champalimaud (other) |
| Locations | 1 site (Lisbon) |
| Trial ID | NCT05441969 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the differences in cortical excitability modulation between patients with Major Depressive Disorder (MDD) and healthy individuals using repetitive Transcranial Magnetic Stimulation (rTMS). The researchers will compare measures of cortical excitability and the degree of modulation in the motor cortex after rTMS application. Additionally, the study will assess changes in cortical excitability in MDD patients after six weeks of antidepressant treatment, while also analyzing cognitive performance through psychophysical tasks. The goal is to clarify the neuroplasticity mechanisms underlying MDD.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Major Depressive Disorder as per DSM-5 criteria.
Not a fit: Patients with severe suicide risk, bipolar disorder, or other significant psychiatric or medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of MDD and improve treatment strategies for patients.
How similar studies have performed: While studies using TMS have shown promise in understanding depression, this specific approach comparing cortical excitability modulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria (clinical groups): 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). Exclusion criteria (clinical groups): 1. Moderate to severe suicide risk; 2. Known personal history of bipolar disorder or psychotic disorder; 3. Alcohol or other substance abuse and/or dependence; 4. Developmental disorder; 5. Dementia; 6. Presence of uncontrolled active medical illness; 7. Known structural lesion of the central nervous system; 8. Electrical or metallic brain implants; 9. Cardiac implants; 10. Epilepsy; 11. Active use of medication known to cause seizures; 12. Pregnancy; 13. 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.
Where this trial is running
Lisbon
- Champalimaud Foundation — Lisbon, Portugal (RECRUITING)
Study contacts
- Principal investigator: Albino J Oliveira-Maia, MD, MPH, PhD — Champalimaud Foundation
- Study coordinator: Sofia Marques
- Email: sofia.marques@research.fchampalimaud.org
- Phone: 00351 210480048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Cortical Excitability Modulation, Transcranial Magnetic Stimulation