JPRN-UMIN000015748已完成1 期
Tipepidine in children with attention deficit/hyperactivity disorder (AD/HD): a Double-blind, Placebo-controlled Trial - Tipepidine in children with attention deficit/hyperactivity disorder (AD/HD): a Double-blind, Placebo-controlled Trial
Department of Psychiatry, Chiba University School of Medicine0 个研究点目标入组 80 人开始时间: 2014年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- 6years-old 至 17years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) History of allergic reaction or hypersensitivity to tipepidine hibenzate. (2) Patients who have not been informed of having the disease at the time of informed consent. (3) Diagnosis of any of the following diseases based on the DSM-5 criteria. Autism Spectrum Disorder, Schizophrenia Spectrum and Other Psychotic Disorders, Neurocognitive Disorders, Substance Related and Addictive Disorders, Feeding and Eating Disorders, Personality Disorders, Paraphilic Disorders. (4) currently receiving medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study. (5) currently receiving medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study. (6) currently receiving medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study. (7) Somatic disorder which requires severe body management or severe meal management. (8) participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention). (9) planning change of treatment because of unstable neurological manifestations or somatic symptoms. (10) History of suicidal ideation within the past year. (11) pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study. (12) Other clinically significant reasons for exclusion by investigators.
研究者
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