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
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
Dr Rachana
Karnataka Medical College And Research Institute Hubballi
