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临床试验/CTRI/2024/10/074777
CTRI/2024/10/074777尚未招募3 期

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS )as an augmenting agent in Treatment Resistant Depression

未提供1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月12日最近更新:

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

发起方
未提供
责任方
Principal Investigator
主要研究者

Vishav Rakesh Damathia

ABVIMS and Dr. Ram Manohar Lohia Hospital

研究点 (1)

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