Long-term Effects of Medication for Attention Deficit Hyperactivity Disorder (ADHD) in Children and Adolescents on Cognition, Everyday Function and Quality of Life
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in CGI - (S and I)
研究概览
简要总结
Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17 years, who receive medication for ADHD of any subtype (presentation). Long-term results are evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales; WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional Impairment Scale; WFIRS), and quality of life (Child Health and Illness Profile-Child Edition Scale; CHIP-CE) during 24 months of ADHD treatment.
详细描述
Single-centre open-label prospective study, including 127 subjects over a period of 2 years. Children and adolescents (6-17 years) who have been diagnosed with ADHD will be enrolled and followed during 24 months of ADHD treatment.
Screening assessments include medical, neurodevelopmental and psychiatric history, clinical evaluation and definition of the ADHD diagnosis and its subtypes or presentations (according to Diagnostic and Statistical Manual (DSM) IV and DSM 5), ADHD symptom severity and global functional impairment (by the investigator-rated ADHD Rating Scale-IV (ADHD-RS-IV) and Clinical Global Impression Scale-Severity and Improvement; CGI-S and CGI-I), comorbidities (by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinical interview), intellectual ability (by the WISC test), and general level of functioning (by the Vineland interview). Subjects previously assessed and diagnosed will be re-assessed at the screening visit to ascertain a current evaluation and definition of these parameters.
At baseline, a Qb-test and an assessment of symptom severity and global functional impairment will be made by the investigator-rated ADHD-RS-IV and CGI-S, everyday functioning by parent-rated WIFRS, and quality of life by parent-rated CHIP-CE. An adverse events report will be collected by interview with open-ended questions. Assignment to treatment will be individualized according to clinical picture and patient preference.
At subsequent visits (1, 2, 3, 6, 12, 18 and 24 months) the following assessments will be performed: Investigator-rated ADHD-RS-IV, CGI-S, Clinical Global Impression-Improvement (CGI-I) scales for symptom severity, global functional impairment and improvement. Adverse event report. Compliance assessment through pill count. Assessment of comorbidity status according to DSM-IV and DSM 5 checklist/interview.
A Qb-test will be performed at the 1 and 12 month visits. Everyday functioning and quality of life will be assessed by parent-rated WIFRS and CHIP-CE scales at the 12 and 24 month visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6-17 years of age
- •Clinical diagnosis ADHD of any subtype and DSM 5 presentation
- •Intellectual ability in the normal range, according to Wechsler tests and clinical judgment
- •Subjects treated with ADHD medication will have a wash-out period prior to Qb-test at baseline, of 1 week for methylphenidate or amphetamine, 2 weeks for atomoxetine
排除标准
- •Physical or psychological limitation making Qb-test unsuitable.
- •Cardiovascular disease, seizures or other unstable medical conditions that might increase the risk for the subject.
- •Bipolar Disorder, Conduct Disorder, Psychosis, severe autism or other severe comorbid or medical conditions that in the investigator's opinion would make study participation unsuitable.
- •Concomitant medications (allowed at investigator's discretion), must be recorded in the subject's medical records and the CRF.
- •Substance use.
研究组 & 干预措施
Children and adolescents with ADHD
Children and adolescents medicating for ADHD of any subtype (presentation) with comorbidities
干预措施: ADHD medications (Drug)
结局指标
主要结局
Change in CGI - (S and I)
时间窗: 0, 1, 2, 3, 6, 12, 18 and 24 months
Investigator-rated clinical global impression scale - severity and improvement
次要结局
- Child Health and Illness Profile - Child Edition (CHIP-CE)(0, 12 and 24 months)
- ADHD Rating Scale(0, 1, 2, 3, 6, 12, 18 and 24 months)
- Qb-test(0, 1 and 12 months)
- WISC-IV(0 and 12 months)
- Vineland scale(0 and 12 months)
- Weiss Functional Impairment Scale (WFIRS)(0, 12 and 24 months)