Menu
Not yet recruiting NCT06714643

Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

No phase Interventional Major Depressive Disorder (MDD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active tDCS, Sham treatment.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Overview

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.

Interventions

  • Device 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 electroencephalograp
  • 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 t

Primary outcome measures

  • Hamilton Depression Rating Scale - 17 (HDRS-17) [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (7)
  • Montreal Cognitive Assessment (MOCA) [Time frame: From enrollment to the end of treatment at 6 months]
  • Frontal Assessment Battery (FAB) [Time frame: From enrollment to the end of treatment at 6 months]
  • Apathy Evaluation Scale (AS) [Time frame: From enrollment to the end of treatment at 6 months]
  • Stroop Color Test [Time frame: From enrollment to the end of treatment at 6 months]
  • To evaluate changes in blood biomarkers after tDCS treatment [Time frame: From enrollment to the end of treatment at 6 months]
  • To evaluate changes in cerebral hemodynamics after tDCS treatment [Time frame: From enrollment to the end of treatment at 6 months]
  • To evaluate changes in Cortical Excitability Using TMS [Time frame: From enrollment to the end of treatment at 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06714643 · 130/2022/PO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗