Home-based Non-invasive Brain Stimulation for Treatment-resistant Depression: Feasibility, Efficacy and Biomarker of Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
Depression has a yearly prevalence superior to 5%, but a 30% of patients cannot benefit of pharmacological treatment, resulting resistant to it.
Transcranial direct current stimulation, due to its reduced invasiveness and easy administration showed to be a useful technique to treat these cases, and it is now broadly used in clinical practice.
Moreover, thanks to technological advances, this treatment could be self-administered at home, reducing costs and improving scalability.
The aim of this study is to confirm the efficacy, safety and feasibility of a home-based intervention for treatment-resistant depression
To do this participants will perform a home-based tDCS intervention consisting of 30 minutes sessions, 5 days per week, for 4 weeks.
Results should provide critical knowledge regarding home-based therapies for the treatment of resistant depression and evidence on brain mechanisms underlying response to non-invasive brain stimulation.
详细描述
Major Depressive Disorder (MDD) is a highly disabling pathology with an important prevalence along the whole lifespan. Its global prevalence is around 5% of the population and it has been estimated that depression represents the third cause of worldwide disability causing an enormous social and economic impact.
While a significant proportion of patients with MDD show clinical responses to first line pharmacological interventions, almost 30% of cases exhibit resistance to medications, and fail to gain remission of symptoms when administered with antidepressants.
This condition, termed treatment-resistant depression (TRD), defines patients where treatment with two or more products of different pharmacological classes used for a sufficient length of time at an adequate dose, fails to induce a clinically meaningful effect (inadequate response).
TRD worsens the personal, social, and economic impact of depression and TRD patients, compared to non-TRD patients, reported reduced quality of life, reduced physical and mental health, presenting important impairments in daily life activities. Furthermore, for these patients, healthcare resources and costs are also significantly higher.
To treat these patients in the last decades various alternative therapeutic approaches have been developed. Between them non-invasive brain stimulation (NIBS) demonstrated to be a safe and effective procedure that successfully reduces and mitigates major depression symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All participants will receive the same treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria and be diagnosed by a Psychiatrist for MDD, according to the Diagnostic and Statistical Manual of Mental Disorders
- •Score at least 20 on the Montgomery-Åsberg Depression Rating Scale
- •Be stable enough to participate in the study without risk for safety.
- •Live with an adult with computer skills and willingness to learn how to use tDCS.
排除标准
- •Present other psychiatric conditions or neurological disorders
- •Abuse of alcohol or drugs
- •Pregnancy
- •Present any contraindication for tDCS
研究组 & 干预措施
Treatment
tDCS stimulation
干预措施: Non-invasive transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Adherence
时间窗: immediately after the intervention
Number of session completed
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: immediately after the intervention
Incidences related with the stimulation
次要结局
- Changes in the Montgomery-Åsberg Depression Rating Scale(baseline and immediately after the intervention)
- Changes in the Quick Inventory of Depressive Symptomatology(baseline and immediately after the intervention)
- Changes in the Beck Depression Inventory(baseline and immediately after the intervention)
- Changes in the Hamilton Depression Rating Scale(baseline and immediately after the intervention)
- Changes in the Montreal Cognitive Assessment(baseline and immediately after the intervention)
- Changes in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form(baseline and immediately after the intervention)
研究者
Gabriele Cattaneo
Principal Investigator
Institut Guttmann