THE EFFECTIVENESS AND SAFETY OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) AS AN ADJUVANT TREATMENT FOR PATIENTS WITH BIPOLAR DEPRESSION - A RANDOMIZED SHAM CONTROLLED TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate effectiveness and safety of tDCS in bipolar depression improvement as measured by
研究概览
简要总结
This study aims to evaluate the effectiveness and safety of Transcranial Direct Current Stimulation that is tDCS as an adjunctive treatment for patients with bipolar depression. Bipolar depression, the more disabling phase of bipolar disorder, is associated with a high risk of suicide, longer illness duration, and poorer response to traditional treatments. While pharmacological and psychotherapeutic approaches remain the standard, many patients do not achieve complete remission, highlighting the need for alternative strategies. tDCS is a non-invasive, affordable, and safe neuromodulation technique that uses low-intensity electrical currents to stimulate targeted brain regions, particularly the left dorsolateral prefrontal cortex, which is often underactive in depression. This randomized, single-blind, sham-controlled trial will be conducted at DIMHANS, Dharwad, with adult patients aged 18 to 60 who meet ICD 11 criteria for bipolar depression and have a BDI score above 19. Participants will receive either active tDCS or sham stimulation over a minimum of 7 sessions. Depression severity will be assessed using the Beck Depression Inventory, and secondary outcomes will include monitoring for side effects, mood switching checked with YMRS, cognitive function by MoCA, and quality of life WHOQOL BREF. The study is expected to recruit 88 participants, accounting for dropout, and statistical analysis will be performed using SPSS software. By generating local data, the study aims to fill a gap in Indian research on tDCS and explore its potential as a safe and effective adjuvant therapy in managing bipolar depression.
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Adult aged 18 to 60 years 2 Any gender 3 Diagnosis of bipolar disorder depressive episodes as per ICD 1 1 criteria 4 Currently experiencing a moderate to severe depressive episode as per BDI score more than 19 5 Able to provide informed written consent.
排除标准
- •1 History of seizures 2 Presence of metal implants pacemakers or other electronic medical devices 3 Pregnancy or breast feeding mother 4 Substance use disorder except nicotine use 5 Use of other neuro modulator treatment in the present admission 6 With active suicide ideations 7 Uncontrolled co morbidities or any neurological disease.
结局指标
主要结局
To evaluate effectiveness and safety of tDCS in bipolar depression improvement as measured by
时间窗: baseline, 2 weeks, one month post intervention
BDI scores
时间窗: baseline, 2 weeks, one month post intervention
次要结局
- To monitor and document any adverse effects, including mood switching using YMRS and tDCS side effects checklist (example hypomania or mania)(Cognitive functioning and evaluation)
研究者
Dr Jayalakshmi M K
Dharwad institute of mental health and neurosciences
