NCT06714643: NIBS_tDCS

Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Not yet recruiting NA Last updated 3 December 2024

What this trial tests

NA trial testing Active tDCS in Major Depressive Disorder (MDD) in 105 participants. Not yet recruiting.

Timeline

2 January 2025

Primary endpoint
2 January 2026

2 January 2026

Quick facts

Lead sponsor	Carmen Concerto
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	105
Start date	2 January 2025
Primary completion	2 January 2026
Estimated completion	2 January 2026

Drugs / interventions tested

• Active tDCS
• Sham treatment — full drug profile →

Conditions studied

• Major Depressive Disorder (MDD) — all drugs for Major Depressive Disorder (MDD) →

Sponsor

Carmen Concerto

Who can join

19 and older, any sex, with Major Depressive Disorder (MDD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antidepressant and Related Neurobiological and Neurophysiological Effects of Add-On Transcranial Direct Current Stimulation in Major Depressive Disorder with Residual Symptoms: A Randomized, Double-Blind Clinical Trial Protocol.
   Concerto C, Bella F, Chiarenza C, Rodolico A, et al · · 2025 · cited 1× · PMID 41149800 · DOI 10.3390/mps8050117