Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 主要终点
- Hamilton Depression Rating Scale - 17 (HDRS-17)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
active
干预措施: Active tDCS (Device)
sham
干预措施: Sham treatment (Device)
结局指标
主要结局
Hamilton Depression Rating Scale - 17 (HDRS-17)
时间窗: 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.
次要结局
- 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)
- To evaluate changes in cerebral hemodynamics after tDCS treatment(From enrollment to the end of treatment at 6 months)
- To evaluate changes in Cortical Excitability Using TMS(From enrollment to the end of treatment at 6 months)
研究者
Carmen Concerto
PhD, MD
University of Catania