JPRN-UMIN000031412已完成2 期
An early phase II trial for efficacy and safety of TTA-121 on autism spectrum disorder - An early phase II trial of TTA-121 on autism spectrum disorder
Hamamatsu University School of Medicine, Department of Psychiatry0 个研究点目标入组 144 人开始时间: 2018年2月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
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
- 18years-old 至 55years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •(1) Diagnosis of bipolar disorder or schizophrenia spectrum disorder (2) Primary diagnosis of depressive disorders, obsessive-compulsive and related disorders, anxiety disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, or neurodevelopmental disorders other than autism spectrum disorder (3) instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders (4) history of changes in medication or doses of psychotropics within one month before registration (5) current treatment with more than one psychotropics (6) history of hyper-sensitivity to oxytocin; (7) history of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes (8) history of alcohol-related disorders, substance abuse, or addiction (9) Family history of male breast cancer (10) Subject who has severe complications (11) Known hypersensitivity to some drugs and foods (12) Subject who is not able to consent contraception during study period (13) Pariticipation in another registration clinical trial and administration of investigational drug during 120 days before informed consent (14) Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study
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