NCT01361815已完成不适用
A Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI) for Subjects With MDD Who Complete/ Discontinued the CTP-0001-00 Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Brainsway
- 入组人数
- 75
- 试验地点
- 30
- 主要终点
- The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications
研究概览
简要总结
The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol# CTP-0001-00).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Men and women 22-68 years of age
- •Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV).
- •Completed the CTP-0001-00 study according to the protocol, i.e., either completed 16 weeks of treatment, or were discontinued from the CTP-0001-00 study protocol after 6 weeks or more from randomization.
- •Capable and willing to provide informed consent.
- •Able to adhere to the treatment schedule.
排除标准
- •Discontinued from CTP-0001-00 study protocol due to the following reasons: Tolerability and safety reason, Non-compliant with the study protocol, Developed documented suicidal ideation as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or suicidal attempt
- •Current psychotic disorder
- •Sensitivity or allergic or other severe adverse event previously reported for Citalopram, Escitalopram, Fluoxetine, Paroxetine, or Sertraline.
- •Known or suspected pregnancy
- •Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
- •Minimal MT found for both hands is higher than 75% of stimulator power output.
结局指标
主要结局
The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications
时间窗: 4 weeks
Safety: AE incidence, Vital signs, Physical and neurological examination, Young Manic Rating Scale (YMRS), Suicide Ideation Scale (SSI) Tolerability: Number of subjects (%) who discontinue the study, Number of subjects (%) who discontinue the study due to AEs
次要结局
未报告次要终点
研究者
研究点 (30)
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