NCT06714643

Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Carmen Concerto · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DEVICE	Active tDCS	The active tDCS protocol consist of 15 excitatory tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC at an intensity of 2 mA. The electrodes are positioned according to the 10-20 electroencephalography system (Anode on F3 and Cathode on F4).
DEVICE	Sham treatment	The sham-tDCS intervention consist of a placebo 15 tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC. During the sessions only a 15-second initiation current is applied, providing the patient with the sensation of receiving an electric current on the scalp. Participants will also experience sounds and stimuli similar to those produced by active tDCS.

Timeline

• Start date: 2025-01-02
• Primary completion: 2026-01-02
• Completion: 2026-01-02
• First posted: 2024-12-03
• Last updated: 2024-12-03