JPRN-jRCT1080225158已完成2 期
Phase II Study of SDT-001 in Pediatric Patients with Attention-deficit/Hyperactivity Disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 262
研究概览
简要总结
The ADHD-RS-IV score (physician's assessment) in the 6-week treatment period and all the endpoints indicated improving trends in the 6-week treatment period in both the SDT-001 group and the Sham group, but no statistically significant difference between the two groups. The above results suggest that SDT-001 may improve ADHD symptoms. There was no specific finding in terms of adverse device effects, and no significant safety concern was suggested during and after use of this device.
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
- •Main Inclusion Criteria
- •-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 judged unlikely to respond to it sufficiently.
排除标准
- •Main Exclusion Criteria
- •-Patients with personality disorder or intellectual disability
- •-Patients who used prohibited concomitant drugs/therapies, or patients who received additional psychosocial treatments (including environmental coordination) or changes in conditions of psychosocial treatments 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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