Effectiveness of of Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression, in TMS Unit, Neurcognitive Lab, Iranian National Center for Addiction Studies (INCAS), in 2011. A Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires.
研究概览
简要总结
Sequential left prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS), with high frequency, for Treatment-Resistant Depression have been shown to have antidepressant effects. but doubts remain about the magnitude of previously demonstrated treatment effects.The aim of this study is To test whether daily weekday left prefrontal rTMS safely and effectively treats Resistant Depression disorder compared to sham controls.
详细描述
Design:
Prospective, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatment (fixed-dose phase) followed by continued blinded treatment for up to another 3 weeks in improvers.
Setting:
University psychiatric hospitals in Tehran including Roozbeh Hospital, Rasool Hospital and Imam Hossein General Hospital will refer clients to Iranian National Center for Addiction Studies, Tehran University of Medical Sciences.
Patients:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of major depression
- •Resistance to treatment as defined by the insufficient clinical benefit to at least one adequate medication trials
排除标准
- •Other current Axis I disorders (except simple phobia and nicotine addiction)
- •Personal or close family history of seizure disorder
- •Ferromagnetic material in body or close to head
- •Neurologic disorder
- •Pregnancy
- •Taking medications known to lower seizure threshold (eg, theophylline)
研究组 & 干预措施
Repetitive Transcranial Magnetic Stimulation
We deliver rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil.
干预措施: Repetitive Transcranial Magnetic Stimulation (Other)
Sham rTMS
Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
干预措施: Sham rTMS (Other)
结局指标
主要结局
change (decrease) of depression according to Hamilton, Beck, BPRS questionnaires.
时间窗: 3 week
The primary outcome measure for the study was score on the MADRS. The patients were assessed with the MADRS, the 17-item version of the Hamilton Depression Rating Scale (HAM-D), the Beck Depression Inventory (BDI), the Brief Psychiatric Rating Scale (BPRS), the CORE Rating of Psychomotor Disturbance (16), and the Global Assessment of Functioning (GAF) Scale (DSM-IVTR).
次要结局
未报告次要终点
研究者
Zahra Khazaeipour
Principal Investigator
Tehran University of Medical Sciences