JPRN-jRCTs032210059招募中2 期
Integrative precision neuromodulation therapy for psychiatric disorders: an open-label, pilot, umbrella basket study - integrative Precision Neuromodulation Therapy: an Umbrella Basket study (iPNT-UB)
Shinsuke Kito0 个研究点目标入组 90 人开始时间: 2021年4月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •For patients with major depressive disorder (MDD)
- •1)are diagnosed as MDD in depressive episode in
- •2)are aged >=18;
- •3)got a total score of >=20 in HAMD-17; and
- •4)did not respond to pharmacotherapy
- •conducted as standard treatments
- •for patients with MDD.
- •For patients with bipolar disorder (BD), those who:
- •1)are diagnosed as BD in in depressive episode in
- •2)are aged >=18;
- •3)got a total score of >=20 in HAMD-17; and
- •4)did not respond to pharmacotherapy
- •conducted as standard treatments
- •for patients with BD in depressive
- •For patients with schizophrenia (SZ), those who:
- •1)are diagnosed as SZ in DSM-5;
- •2)are aged >=18;
- •3)got a total score of >=60 in PANSS; and
- •4)did not respond to pharmacotherapy
- •conducted as standard treatments
- •for patients with SZ.
- •For patients with obsessive-compulsive disorder
- •1)are diagnosed as OCD in DSM-5;
- •2)are aged >=18;
- •3)got a total score of >=20 in YBOCS; and
- •4)did not respond to pharmacotherapy and/or
- •psychotherapy conducted as standard treatments
- •for patients with OCD.
排除标准
- •1)patients who have concurrent mental disorders
- •such as autism spectrum disorder (ASD), attention
- •deficit hyperactive disorder (ADHD),
- •post-traumatic stress disorder (PTSD),
- •dissociative disorder, eating disorder,
- •substance-related disorder, and/or
- •personality disorder;
- •2)patients in pregnancy or lactating patients;
- •3)patients with a present or past history of
- •convulsive disorder (epilepsy, etc.) and their
- •first degree relatives with the same disorder;
- •4)patients with a present or past history of
- •neurological disorders or organic brain
- •5)patients having magnetic substance which can
- •be hardly extracted such as a pacemaker, artificial
- •inner ear, and intracranial clip;
- •6)patients having physical disease such as severe
- •metabolic disease and endocrine disease;
- •7)patients with severe suicidal ideation; or
- •8)patients deemded inappropriate to participate
- •by judgement of principal investigator
研究者
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