Clinical trial NCT06714643: Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
Official title: Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: tDCS
MD
Biomarkers
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 105
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hamilton Depression Rating Scale - 17 (HDRS-17)
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: From enrollment to the end of treatment at 6 months
measure: Frontal Assessment Battery (FAB)
timeFrame: From enrollment to the end of treatment at 6 months
measure: Apathy Evaluation Scale (AS)
timeFrame: From enrollment to the end of treatment at 6 months
measure: Stroop Color Test
timeFrame: From enrollment to the end of treatment at 6 months
measure: To evaluate changes in blood biomarkers after tDCS treatment
timeFrame: From enrollment to the end of treatment at 6 months
measure: To evaluate changes in cerebral hemodynamics after tDCS treatment
timeFrame: From enrollment to the end of treatment at 6 months
measure: To evaluate changes in Cortical Excitability Using TMS
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Catania
name: Maria Salvina Signorelli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: