Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Introduction The study involves the recruitment of outpatients suffering from Major Depressive Disorder (MDD), diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Patients are on selective serotonin reuptake inhibitors (SSRIs) for at least 4 weeks and present residual depressive symptoms, defined by a score greater than 7 on the Hamilton Depression Rating Scale (HDRS-17). Study Objectives Primary Objective To investigate the effects of transcranial direct current stimulation (tDCS) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group. Secondary Objectives To investigate the effects of tDCS on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. To evaluate changes in blood biomarkers, neurophysiological, and neurosonological variables after tDCS treatment in the same group of patients.

NCT Number	NCT06714643
Lead Sponsor	Carmen Concerto
Conditions	Major Depressive Disorder (MDD)
Enrollment	105 participants
Start Date	2025-01-02
Primary Completion	2026-01-02 (estimated)
Study Completion	2026-01-02 (estimated)
Updated on ClinicalTrials.gov	2024-12-03