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临床试验/CTRI/2026/04/108659
CTRI/2026/04/108659尚未招募2 期

To determine efficacy High Frequency Repetitive Transcranial magnetic Stimulation In The Management Of Treatment Resistant Depression A Single Blind Randomised Sham Controlled Study From North Karnataka

Dr Rachana Maiya1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2028年6月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
56
试验地点
1

研究概览

简要总结

To assess the efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation in treatment resistant depression is single blind randomised sham Controlled trial with eligible,consented , adults of 18-65years with treatment resistant depression ( Operational definition According to Ruhe and colleague) satisfying all inclusion and exclusion criteria ( excluding pregnancy, substance use disorder except nicotine use disorder, epilepsy, vascular,brain lesions , psychosis, implanted ferromagnetic device or ones who had ECT excluded ) are recruited,with sample size of 56  participants randomised in a 1:1 ratio to active rTMS(modified accelerated intermittent theta bursts stimulation at 600 pulses/ session over 3-10 minutes 3 pulses at frequency of 50 hertz every 200 msec with motor threshold of 90% ,2sessions / day with minimum gap of 45 minutes for 10 days ,total 20 session ,at left DLPFC. Using standard localising technique)  or sham rTMS ( clicking sounds / tapping without delivery of magnetic stimulation) using fixed block randomisation,with allocation concealment sequentially numbered ,sealed opaque envelopes , participants and outcome assessors are blinded and treatment provider is not blinded , to intervention, ,primary outcome to assess treatment response using Montgomery Asberg Depression Rating scale baseline end of 10 days ,4th week and 8 th week of treatment and study period is over duration of  12 months.

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

  • Patients willing and able to give written informed consent coming to psychiatry OPD screened using PHQ9 with score more than equal to 10 , current depressive episode, without psychotic features , satisfying operational definition of treatment resistant depression failed to respond atleast 2 adequate trials of antidepressants for duration of 4-6 weeks , preferably from 2 different pharmacological classes ,with confirmed treatment adherence response of less than 50% reduction in symptoms.

排除标准

  • Refuse consent for study ,who underwent other neuromodulation like ECT , who is substance disorder except nicotine use disorder , medical comorbidity such as epilepsy, vascular,traumatic ,tumors ,infectious or metabolic lesion , pregnancy,implanted ferromagnetic device ,associated with psychosis.

研究者

发起方
Dr Rachana Maiya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rachana

Karnataka Medical College And Research Institute Hubballi

研究点 (1)

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