Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder (NIBS_tDCS)

Carmen Concerto

Status

Not yet enrolling

Conditions

Major Depressive Disorder (MDD)

Treatments

Device: Active tDCS

Device: Sham treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06714643

130/2022/PO

Details and patient eligibility

About

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.

Enrollment

105 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with Major Depressive Disorder (MDD), as defined by the DSM-5-TR criteria;
Presence of residual symptoms, defined by a Hamilton Depression Rating Scale score over 7;
Age over 18 years.

Exclusion criteria

MMSE under 18 and/or CDR over 2;
Other neurological diseases (stroke, multiple sclerosis, major head trauma, epilepsy) or psychiatric disorders other than those included (schizophrenia, bipolar disorder, etc.);
Patients with severe clinical conditions, acute or uncontrolled chronic medical diseases;
Endocrine diseases, vitamin deficiencies, or exposure to drugs associated with cognitive impairment and/or mood deflection;
Alcohol abuse or recreational drug use;
Contraindications to MRI and TMS (carriers of implanted devices, patients who have undergone craniotomy, presence of metal fragments or prostheses, history of epilepsy);
Pregnant or breastfeeding women.