Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Hamilton Depression Rating Scale - 17 (HDRS-17) [Срок оценки: From enrollment to the end of treatment at 6 months]

Вторичные конечные точки (7)

• Montreal Cognitive Assessment (MOCA) [Срок оценки: From enrollment to the end of treatment at 6 months]
• Frontal Assessment Battery (FAB) [Срок оценки: From enrollment to the end of treatment at 6 months]
• Apathy Evaluation Scale (AS) [Срок оценки: From enrollment to the end of treatment at 6 months]
• Stroop Color Test [Срок оценки: From enrollment to the end of treatment at 6 months]
• To evaluate changes in blood biomarkers after tDCS treatment [Срок оценки: From enrollment to the end of treatment at 6 months]
• To evaluate changes in cerebral hemodynamics after tDCS treatment [Срок оценки: From enrollment to the end of treatment at 6 months]
• To evaluate changes in Cortical Excitability Using TMS [Срок оценки: From enrollment to the end of treatment at 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06714643 · 130/2022/PO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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