Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

NCT ID: NCT06714643

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2026-01-02

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: 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

Group Type: SHAM_COMPARATOR

Sham treatment

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmen Concerto

OTHER

Sponsor Role: lead

Responsible Party

Carmen Concerto

PhD, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maria Salvina Signorelli, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Central Contacts

Maria Salvina Signorelli, MD PhD

Role: CONTACT

maria.signorelli@unict.it

3498127364

Carmen Concerto, MD PhD

Role: CONTACT

c.concerto@policlinico.unict.it

Other Identifiers

130/2022/PO

Identifier Type: -

Identifier Source: org_study_id