NEURAPAS Balance in Children With Nervous Restlessness, e.g. Agitated Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in Parent Child Behaviour Checklist (CBCL/4-18)
研究概览
简要总结
Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12.
Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.
详细描述
Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12.
Patients and methods: A prospective, non-interventional, non-randomized, observational study conducted in German pediatric practices. Each patient is treated with NPB. No placebo group is established. As subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS) is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •patients <6 and >12 years of age
结局指标
主要结局
Change in Parent Child Behaviour Checklist (CBCL/4-18)
时间窗: after 2 + 4 weeks´ treatment
Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire
次要结局
- Change of the impact of the child´s complaints on daily family life (VAS)(after 2 + 4 weeks)
- Tolerability of NEURAPAS balance(after 2 + 4 weeks)
- Change of 13 common symptoms of nervous restlessness(after 2 + 4 weeks)