In Vivo Cortical Excitability Modulation in Major Depressive Disorder

NCT05441969 | Recruiting

• 1 other identifier: PDM-TMS
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Cortical Excitability Modulation; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Left cortical excitability modulation changes according to treatment response

  Baseline and after ~6 weeks.

Study Arms (3)

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).

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).

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.

Other: No intervention/expousure

Interventions

No intervention/expousure OTHER

No interventions/expousure since this is an observational study.

Current major depressive episode group; Healthy subjects group; Maintenance antidepressant treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \. 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).

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fundacao Champalimaud: lead

Study Sites (1)

Champalimaud Foundation

Lisbon, 1400-038, Portugal

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Albino J Oliveira-Maia, MD, MPH, PhD

  Champalimaud Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Marques

CONTACT

00351 210480048; sofia.marques@research.fchampalimaud.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neuropsychiatry Unit, Champalimaud Foundation

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: May 19, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)