Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS )as an augmenting agent in Treatment Resistant Depression
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- improvement in scores of HAMD/HDRS, MADRS over 4 weeks
研究概览
简要总结
The study will be conducted at the Department of Psychiatry, CEIMH, ABVIMS, and Dr. RML Hospital, New Delhi. It is designed as a prospective interventional study, focusing on patients with depression secondary to chronic medical illness. Following ethical clearance, participants aged 18-65 who met DSM-5 criteria for depression, had HAM-D scores greater than 8, and were resistant to two antidepressant trials were recruited. Exclusion criteria were comorbid psychotic disorders, epilepsy, substance abuse, metal implants, pregnancy, and recent brain stimulation or psychosurgery. Eligible participants, who met the inclusion criteria, were informed about the study’s purpose, duration, and potential benefits and risks. No compensation was provided. Informed consent was obtained using an Ethics Committee-approved form, with relatives encouraged to participate for comprehensive data collection.
Consenting subjects and their unaffected relatives will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), HAM-D, PSQI, and MoCA. rTMS sessions will be conducted over two weeks, with 10 sessions targeting the left dorsolateral prefrontal cortex (F3). Depression, cognitive impairment, and sleep quality were evaluated at baseline, two weeks post-treatment, and four weeks post-treatment. Participants were fully informed about the rTMS procedure and shown an educational video. Data were analyzed and compared after the study’s completion.
previous similaCTRI registered studies
CTRI/2018/02/011890
CTRi/2024/01/061590
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •no response to two antidepressant trials of six weeks each criteria for depression hamd score of more than eight.
排除标准
- •Psychotic Disorder Epilepsy Substance Abuse Metal Implants Pregnancy Recent Brain Surgery or Psychosurgery.
结局指标
主要结局
improvement in scores of HAMD/HDRS, MADRS over 4 weeks
时间窗: 2 and 4 weeks post intervention
次要结局
- improvement in scores of PSQI and MOCA over 4 weeks(2 and 4 weeks post intervention)
研究者
Vishav Rakesh Damathia
ABVIMS and Dr. Ram Manohar Lohia Hospital
