Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Not Applicable

Not yet recruiting

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT06714643
• Lead Sponsor: Carmen Concerto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-16
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Study Start: 2025-01-02
• Primary Completion: 2026-01-02
• Study Completion: 2026-01-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale - 17 (HDRS-17)	From enrollment to the end of treatment at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MOCA)	From enrollment to the end of treatment at 6 months	To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group.; Lower scores suggest greater cognitive impairment, while higher scores indicate better cognitive performance. Below are the minimum and maximum scores and their meaning: 30-26: normal cognitive function; 25-18: mild cognitive impairment; 17-10: moderate cognitive impairment; 9-0: severe cognitive impairment.
Frontal Assessment Battery (FAB)	From enrollment to the end of treatment at 6 months	To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. Specifically, FAB is a tool used to evaluate frontal lobe functions, such as executive functioning. Lower scores suggest greater impairment of frontal lobe functions, while higher scores indicate better functioning. Below are the minimum and maximum scores and their meaning: 18-15: normal frontal lobe functioning; 14-12: mild impairment; 11-9: moderate impairment; 9-0: severe impairment.
Apathy Evaluation Scale (AS)	From enrollment to the end of treatment at 6 months	To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. AS is a tool used to assess the presence of apathy in patients. Higher scores suggest greater severity of apathy, while lower scores indicate better motivation and engagement. Below are the minimum and maximum scores and their meaning: 18-27: no clinically significant apathy; 28-41: mild apathy; 42-55: moderate apathy; 56-72: severe apathy.
Stroop Color Test	From enrollment to the end of treatment at 6 months	To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. Stroop Color Test is a neuropsychological tool used to assess cognitive flexibility, selective attention and processing speed. Performance is assessed by comparing raw scores to normative data adjusted for age, education and cultural background. Minimum score (0) indicates no ability to perform the task; on the other hand, there is no universal maximum score. Tipically, performance is categorized into a normal range when it is consistent with age-matched norms; mild impairment when the performance is slightly below expectations for age or education; moderate to severe impairment when patient shows significant difficulty with cognitive control or selective attention.
To evaluate changes in blood biomarkers after tDCS treatment	From enrollment to the end of treatment at 6 months	A blood sample is collected at enrollment and after tDCS/sham treatment to evaluate biomarkers, including BDNF, NGF, VEGF, IGF1, Ang, Nrg1, IL-6, and TNFα.; Concentrations will be reported in pg/mL or ng/mL, as appropriate for each biomarker.
To evaluate changes in cerebral hemodynamics after tDCS treatment	From enrollment to the end of treatment at 6 months	A transcranial Doppler (TCD) exam is conducted to assess cerebral hemodynamics. Parameters including VPS (cm/s), EDV (cm/s), MBFV (cm/s), PI (unitless), and RI (unitless) are recorded bilaterally from the middle cerebral arteries and the basilar artery, both at rest and after breath-holding tests. Measurements will be reported in their respective units (e.g., cm/s for velocities, unitless for indices).
To evaluate changes in Cortical Excitability Using TMS	From enrollment to the end of treatment at 6 months	Cortical excitability is evaluated using transcranial magnetic stimulation (TMS) with single- and double-pulse protocols. Parameters include: Resting motor threshold (rMT, % of maximum stimulator output); Cortical silent period (cSP, milliseconds); Motor evoked potential (MEP, µV); Paired-pulse stimulation (BiSTIM) is used to study inhibitory and excitatory circuits, including intracortical inhibition (ICI) and intracortical facilitation (ICF).; Results are reported in their respective units (e.g., % stimulator output for rMT, ms for cSP, µV for MEP).