Effectiveness of repetitive transcranial magnetic stimulation as an add on therapy in depressive disorder
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in depressive symptom severity as measured by the Montgomery–Asberg Depression Rating Scale (MADRS)
概览
简要总结
This study is a randomized controlled trial evaluating the effectiveness of repetitive transcranial magnetic stimulation therapy in patients with depressive disorder.
The intervention group will receive active repetitive transcranial magnetic stimulation (10 Hz over the left dorsolateral prefrontal cortex) alongside standard SSRI/SNRI medication, while the control group will receive sham repetitive transcranial magnetic stimulation with medication.
The primary objective is to assess changes in depressive symptoms using the Montgomery–Asberg Depression Rating Scale (MADRS), with secondary outcomes measuring cognitive improvements via the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), and Stroop Test.
The study will include 70 participants (35 per group) aged 18–65 with moderate to severe depression, excluding those with neuropsychiatric comorbidities or contraindications to repetitive transcranial magnetic stimulation.
Ethical approval has been obtained, and informed consent will be secured from all participants.
The trial will run for 18 months, with follow-ups at 2 and 4 weeks post-intervention.
Statistical analysis will compare outcomes between groups to determine repetitive transcranial magnetic stimulation efficacy in treating depression and enhancing cognitive function.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderate to severe depressive disorder as per ICD 11 Diagnostic Criteria (MADRS greater than or equal to 20) Treatment naive or not taking any antidepressant therapy since the last 4 weeks Individuals who can read and write in either Hindi or English language.
排除标准
- •Patients with any other neuropsychiatric disorders such as schizophrenia epilepsy dementia and bipolar disorder Organic diseases leading to depression Other serious underlying diseases organ dysfunction and malignant tumor comorbidities History of brain surgery and injury Patients with High Suicidal Risk based on clinical assessment Contraindications to medication and treatment methods in this study such as ferromagnetic implants in the head a history of neurosurgical operations or a pacemaker implant medication that lower the threshold of epileptic seizures (eg Clozapine Pethidine Aminophylline).
结局指标
主要结局
Change in depressive symptom severity as measured by the Montgomery–Asberg Depression Rating Scale (MADRS)
时间窗: Baseline | At 4 weeks and at 6 weeks
次要结局
- Change in cognitive function, as measured by the Montreal Cognitive Assessment (MoCA) + Trail Making Test (TMT) + Stroop Test(Baseline measurement before giving rTMS and follow up measurement at 2 weeks and 4 weeks after giving rTMS.)
研究者
SHIVRAM
Vardhman Mahavir Medical College Safdarjung Hospital