Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- ADHD classification
研究概览
简要总结
The practicality of most ADHD medications is not or only moderately examined under long term routine conditions. Therefore, in this multi-centre, multi-national prospective non-interventional study, a recommended follow-up time of 12 months will investigate the course of the therapy in children and adolescents with ADHD with prior MPH treatment and their medication change to dexamfetamine in several European countries under daily routine.
It consists of a baseline visit under MPH or another ADHD drug therapy, a change to dexamfetamine, the prospective description of the titration phase and a 12 month maintenance phase. Data on the use of dexamfetamine in routine clinical practice will be collected to describe how dexamfetamine is prescribed, titrated and used in the population of ADHD patients and how these factors influence the general intensity of ADHD and safety events. This study will collect real world data of dexamfetamine and compare descriptively the general intensity of ADHD according to ADHD classification and the impairment due to ADHD under therapy with dexamfetamine to the general intensity of ADHD according to ADHD classification and the impairment due to ADHD under the prior therapy with MPH. Furthermore the utilization of dexamfetamine will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation. Due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 215 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 6 to 17.11 years
- •Current MPH therapy insufficient
- •ADHD was classified according to a validated classification system (e.g. DSM or ICD-10)
- •No contraindication against dexamfetamine
排除标准
- •Contraindication against dexamfetamine
结局指标
主要结局
ADHD classification
时间窗: baseline until 1st follow-up visit after 6 months
change from baseline under MPH therapy to the 1st follow-up visit after 6 months under dexamfetamine, assessment by ADHD Rating Scale IV
次要结局
- ADHD classification subgroup: Age(baseline until 1st follow-up visit after 6 months)
- ADHD classification subgroup: Dose under MPH therapy(baseline until 1st follow-up visit after 6 months)
- ADHD classification subgroup: Dose under dexamfetamine therapy(baseline until 1st follow-up visit after 6 months)
- ADHD classification subgroup: Baseline ADHD classification(baseline until 1st follow-up visit after 6 months)
- Dose-response relationship between dose under dexamfetamine and ADHD classification at 1st follow-up(at 1st follow-up visit, 6 months after baseline)
- ADHD classification change from baseline to titration and from baseline to 2nd follow-up after 1 year under dexamfetamine(baseline until 2nd follow-up visit after 1 year of examination)
- Subscales hyperactivity/impulsivity(baseline until 2nd follow-up visit after 1 year of examination)
- Subscales inattention(baseline until 2nd follow-up visit after 1 year of examination)
- Response rate, relative reduction in ADHD classification from baseline to 1st follow-up of 30% or more(baseline until1st follow-up visit after 6 months)
- Overall impairment of the patient's everyday life and disability due to ADHD concerning home life(baseline until 2nd follow-up visit after 1 year of examination)
- Overall impairment of the patient's everyday life and disability due to ADHD concerning friendships(baseline until 2nd follow-up visit after 1 year of examination)
- Overall impairment of the patient's everyday life and disability due to ADHD concerning classroom learning(baseline until 2nd follow-up visit after 1 year of examination)
- Overall impairment of the patient's everyday life and disability due to ADHD concerning leisure activities(baseline until 2nd follow-up visit after 1 year of examination)
- Compliance of last MPH intake(baseline)
- Compliance of last ADHD medication intake (other than MPH)(baseline)
- Compliance of dexamfetamine intake(titration until 2nd follow-up visit after 1 year of examination)
- Adverse Drug Reactions under ADHD medication, assessment of blood pressure in mmHg(baseline until 2nd follow-up visit after 1 year of examination)
- Adverse Drug Reactions under ADHD medication, assessment of pulse in beats/min(baseline until 2nd follow-up visit after 1 year of examination)
- Adverse Drug Reactions under ADHD medication, assessment of weight in kg(baseline until 2nd follow-up visit after 1 year of examination)
- Adverse Drug Reactions under ADHD medication, assessment of height in cm(baseline until 2nd follow-up visit after 1 year of examination)