JPRN-jRCT2042220012进行中（未招募）3 期
Phase 3 study of SDT-001 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder consisting of randomized, open-label, nomal treatment-control, conparison part and extension, open-label, re-treatment part
agata - Tsutae0 个研究点目标入组 150 人开始时间: 2022年4月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- >= 6age old 至 <= 17age old（—）
- 性别
- All
入选标准
- •Patients diagnosed with ADHD according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) at the time of obtaining informed consent.
- •Patients who have received psychosocial treatment (including environmental coordination) for ADHD for a sufficient duration at the time of obtaining informed consent, and who are considered unlikely to respond to it sufficiently.
排除标准
- •Patients with personality disorder or intellectual disability
- •Patients who used prohibited concomitant drugs/therapies, during the screening period.
- •Patients with suspected gaming disorder [conditions in which video games significantly interfere with daily life (e.g., school life or sleep)]
研究者
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