Transcranial Direct Current Stimulation (tDCS) as an Adjuvant Therapy in Patients with Late-Life Depression (LLD): A Single-Blind, Randomized, Sham-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Assessment of efficacy of tDCS as an adjuvant to anti depressants in patients
研究概览
简要总结
Late-life depression (LLD) affects individuals aged 60 and older, often complicating treatment due to comorbid conditions and lower efficacy of standard treatments like antidepressants and psychotherapy, tDCS is a non-invasive technique that uses mild electric currents through scalp electrodes to modulate brain activity, enhance synaptic release, and improve neural plasticity. It addresses hypoactivity and low serotonin levels in the dorsolateral prefrontal cortex (DLPFC), a key area affected in depression. Unlike traditional antidepressants, which take time to show effects, and electroconvulsive therapy (ECT), which is invasive, tDCS offers a quicker, non-invasive alternative.
This study aims to assess the effects of transcranial direct current stimulation (tDCS) as an adjuvant to antidepressants in patients with late-life depression, as well as its impact on cognitive functions, by comparing it to a sham tDCS group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.60 years of age or older and diagnosed with Late Life Depression.
- •All patients who give valid consent.
排除标准
- •1 Patients who are less than 60 years of age.
- •Other psychiatric comorbidities except mild anxiety.
- •Substance use disorder except tobacco.
- •High risk for suicide.
- •Serious brain diseases or unstable medical conditions that impairs decision taking capacity.
- •Any other significant communication barrier.
结局指标
主要结局
Assessment of efficacy of tDCS as an adjuvant to anti depressants in patients
时间窗: 1 YEAR
diagnosed with late life depression in comparison with sham controlled tDCS.
时间窗: 1 YEAR
次要结局
- 1 To assess for rapid antidepressant effect of tDCS as an adjuvant to antidepressants in patients diagnosed with Late Life Depression.
研究者
Jahanvi Zandawala
JAWAHARLAL NEHRU MEDICAL COLLEGE