Randomised Controlled Single Blind Trial of Transcranial Direct Current Stimulation(tDCS) as Early Augmentation in Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study efficacy of transcranial direct current stimulation in Major Depressive Disorder
研究概览
简要总结
Major Depressive Disorder (MDD) has the highest lifetime prevalence among various psychiatric disorders. It leads to poor quality of life and impaired role functioning. Many pharmacological (antidepressants) and non-pharmacological modalities (cognitive behavioural therapy) are used for the management. Despite adequate treatment, 20-30% of patients could not achieve remission. Various augmentation strategies are then used. Neuromodulation strategies repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS) have been implicated in refractory cases.
tDCS has been found to be effective in managing depressive symptoms in various RCTs but its role as an early augmentation strategy has not been studied much. It is a relatively novel non-pharmacological intervention that has significant advantages over other Brain Stimulation Techniques in terms of portability, cost-effectiveness and safety.
This study aims to determine the efficacy & safety of Transcranial Direct Current Stimulation (tDCS) as early augmentation in Drug Naive Patients with Major Depressive Disorder.â€
Procedure:
Patients will be recruited from the Adult Psychiatry Outpatient Services and Emergency Services, King George Medical University, Lucknow, Uttar Pradesh, India. Patients fulfilling the selection criteria will be enrolled and written informed consent will be taken. On the day of enrollment, Hamilton- Depression Rating Scale (HAM-D) and Beck’s Depression Inventory (BDI) will be a applied to assess severity of depressive symptoms and Hamilton- Anxiety Rating Scale (HAM-A) for anxiety symptoms. tDCS side effects check-list will be applied to monitor the side-effects. Patients will be randomly allocated to two groups (Active and Sham tDCS) by random table method. Both groups of patients will be blind to the therapy procedure and prescribed uniform antidepressant medications. tDCS will be delivered as per the protocol. A total of 10 sessions will be given within 2 weeks and assessments will be done at baseline, week 2 and week 4 of the enrollment.
Result:
After data collection, statistical analysis will be done using a computerised statistical program, Statistical Package for Social Sciences (SPSS). Mean change in rating scales will be compared after each assessment as well as between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Age 18-60 years
- •Patients diagnosed with Major Depressive Disorder according to DSM-5
- •Willing to give Informed consent to participate in the study.
- •Drug Naive (at least drug free for the past 1 month).
排除标准
- •Patients with Treatment Resistant Depression.
- •Patients having Psychotic Depression.
- •Suicidal Patients
- •HAM-D (Hamilton Depression Rating Scale) less than 13
- •Medical co-morbidities that need immediate attention.
- •Any contraindications to tDCS.
- •Patients with any other co-morbid psychiatric disorder except Tobacco use disorders.
结局指标
主要结局
To study efficacy of transcranial direct current stimulation in Major Depressive Disorder
时间窗: Assessment at 0, 2 and 4 weeks
次要结局
- To study safety of transcranial direct current stimulation in Major Depressive Disorder(Assessment at each session)