Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

ConditionMajor Depressive Disorder (MDD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorCarmen Concerto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Active tDCS
Device
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).
Sham treatment
Device
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.

Treatment groups

105 Participants

are divided into 2 treatment groups

Group A: activeExperimental treatment 1 intervention

Group B: shamSham comparator 1 intervention

Trial outcomes

Primary outcomes

Hamilton Depression Rating Scale - 17 (HDRS-17)

To investigate the effects of transcranial direct current stimulation (tDCS) treatment by administering Hamilton Depression Rating Scale - 17 (HDRS-17) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group. Higher scores indicate greater severity of depressive symptoms, and thus a worse outcome. The minimum and maximum scores and their meaning are as follows: 0-7: No clinically significant depression; 8-13: mild depression; 14-18: moderate depression; 19-22: severe depression; 23-52: very severe depression.

Time frame