Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

NCT06714643 | Not Yet Recruiting DMC

• 1 other identifier: 130/2022/PO
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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)

Keywords

tDCS; MD; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (7)

• Montreal Cognitive Assessment (MOCA)

  From enrollment to the end of treatment at 6 months

• Frontal Assessment Battery (FAB)

  From enrollment to the end of treatment at 6 months

• Apathy Evaluation Scale (AS)

  From enrollment to the end of treatment at 6 months

• Stroop Color Test

  From enrollment to the end of treatment at 6 months

• To evaluate changes in blood biomarkers after tDCS treatment

  From enrollment to the end of treatment at 6 months

Study Arms (2)

active

EXPERIMENTAL

Device: Active tDCS

sham

SHAM COMPARATOR

Device: Sham treatment

Interventions

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).

active

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.

sham

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmen Concerto: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Maria Salvina Signorelli, MD PhD

  University of Catania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Salvina Signorelli, MD PhD

CONTACT

3498127364; maria.signorelli@unict.it

Carmen Concerto, MD PhD

CONTACT

c.concerto@policlinico.unict.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: December 3, 2024
• Study Start: January 2, 2025
• Primary Completion: January 2, 2026
• Study Completion: January 2, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11