Major Depressive Disorder - MDD
Conditions
Interventions
This is a randomized, placebo-controlled, double-blind clinical trial consisting of four intervention arms. After initial assessments (BDI-II, HAM-D, WHOQOL-BREF scales) and a pre-intervention EEG rec
Sponsors
Instituto de Ensino e Pesquisa Alberto Santos Dumont
Instituto de Ensino e Pesquisa Alberto Santos Dumont
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Individuals diagnosed with Major Depressive Disorder (MDD) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision (DSM-5-TR); age between 18 and 65 years; be literate; score of at least 18 points on the Hamilton Depression Rating Scale (HAM-D); agreement to participate in the study, by signing the Informed Consent Form (ICF); clinical stability, with no significant changes in medication treatment in the last 4 weeks; being in stable psychotherapeutic and/or medication follow-up for at least 4 weeks
Exclusion criteria
Exclusion criteria: Diagnosis of severe comorbid psychiatric disorders (Bipolar Disorder, Schizophrenia); history of neuromodulatory interventions (such as Transcranial Direct Current Stimulation (tDCS) or Transcranial Magnetic Stimulation (TMS)) in the last 6 months; current use of illicit drugs or substance abuse; medical conditions that contraindicate the use of electrical stimulation (severe heart disease, epilepsy, etc); pregnant or lactating women; presence of a pacemaker, metal implants, or other electronic devices in the body; not being in stable psychotherapeutic and/or medication follow-up for at least 4 weeks; changing or discontinuing medications during the protocol; presenting a significant suicide risk according to the Suicidal Ideation Questionnaire (SIQ)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction of Major Depressive Disorder (MDD) symptoms and the improvement in depressed mood, verified by the application of the Hamilton Depression Rating Scale (HAM-D) and the Beck Depression Inventory-II (BDI-II), based on the comparison of measurements obtained before, during, and after the treatment protocol of the interventions (Transcranial Direct Current Stimulation (tDCS) and transcutaneous spinal Direct Current Stimulation (tsDCS)) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the impacts of neuromodulation (Transcranial Direct Current Stimulation (tDCS) and transcutaneous spinal Direct Current Stimulation (tsDCS)) on participants' quality of life, verified by the application of the WHOQOL-BREF (World Health Organization Quality of Life - Bref) scale, based on the comparison of measurements obtained before, at midpoint, and after the intervention protocol;To analyze the effects of the interventions (transcutaneous spinal Direct Current Stimulation (tsDCS) and Transcranial Direct Current Stimulation (tDCS)) on brain activity, verified by 16-channel Electroencephalogram (EEG) recording, based on the comparison of pre- and post-intervention recordings;To evaluate the placebo effects in relation to Transcranial Direct Current Stimulation (tDCS) and transcutaneous spinal Direct Current Stimulation (tsDCS), verified by the application of outcome scales (HAM-D, BDI-II, WHOQOL-BREF), based on the comparison of responses from the placebo-tDCS and placebo-tsDCS groups with the groups that received active stimulation;To monitor the tolerability, safety, and variables related to possible worsening (adverse events) during the study, verified by a monitoring questionnaire applied at each session, based on the analysis of the frequency and intensity of reported discomfort or worsening of symptoms (such as mood instability, pessimistic thoughts, or adverse skin reactions) | — |
Countries
Brazil
Contacts
Public ContactWíviny Martins
Instituto de Ensino e Pesquisa Alberto Santos Dumont
Outcome results
None listed