JPRN-jRCTs062180023已完成1 期
An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders - The development of treatment for mood disorder by TMS
Okamoto Yasumasa0 个研究点目标入组 3 人开始时间: 2019年2月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
Recruiting did not proceed and the research was discontinued.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old(—)
- 性别
- All
入选标准
- •[ For patients/clients ]
- •1) Aged 20-80 years old
- •2) Being diagnosed as major depressive disorder or bipolar disorder (Type I, Type II) according to DSM-IV-TR or DSM-V
- •3) Current diagnosis of major depressive episode
- •4) Present treatment-resistance (scores with 14 points or above out of 17 items on the Hamilton Rating Scale for Depression even after >=4 weeks of treatment with sufficient amount of more than 2 kinds of anti-depressants) or low treatment-tolerance (insufficient administration due to side-effects while taking more than 2 kinds of anti-depressants)
- •5) Satisfactory informed consent obtained from participant him/herself
- •[ For healthy control ]
- •1) Aged 20-80 years old
- •2) No history of any psychiatric disorders
- •3) Not having current serious medical illness
- •4) Satisfactory informed consent obtained from the participant him/herself
排除标准
- •Rejection criteria common to both patients and healthy controls
- •1) Decisionally impaired individuals who has diminished capacity to understand the aim of the research
- •2) Physically impaired individuals who are not able to complete the experiments
- •3) Subjects who are contraindicated for the use of TMS and MRI
- •Having an implanted heart pace-maker
- •Having implanted cerebral (arteries) clips
- •Having implanted neural/nerve stimulators
- •Having implanted pumps
- •Having work experience in a metal industry or possibility of metal residues remaining in the body
- •Having metal-tattoos (including tattooed eye-lining)
- •Being pregnant, or having possibility of being pregnant
- •4) Subjects who are contraindicated for the use of TMS
- •Personal history of seizure disorder such as epileptic disorder
- •5) Any individuals judged as inappropriate for the experiment by the principal investigator or a collaborating researcher
- •6)Those participating in other intervention studies
研究者
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