A Multicenter Open Trial to Evaluate the Effectiveness and Quality of Life in Adults With Attention Deficit /Hyperactivity Disorder (ADHD) Treated With Long Acting Methylphenidate (CONCERTA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the treatment on quality of life of long-acting methylphenidate in adult participants with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in childhood and is characterized by inadequate levels of attention, hyperactivity and impulsiveness.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with ADHD. The study will consist of 2 phases; a screening phase and a treatment phase. The duration of participation in the study for an individual participant will be up to 12 weeks. Participants will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day (mg/day) on Day 8. Depending on response, tolerability and clinician's judgment, the dose could be escalated to the next dose level of 54 mg/day on Day 28 to a maximum of 72 mg/day on Day 56, until each participant achieved optimal dose. Participant's safety will be monitored throughout the study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Methylphenidate
干预措施: Long-Acting Methylphenidate (Drug)
结局指标
主要结局
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4
时间窗: Baseline and Week 4
Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8
时间窗: Baseline and Week 8
Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12
时间窗: Baseline and Week 12
Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4
时间窗: Baseline and Week 4
The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12
时间窗: Baseline and Week 12
The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.
次要结局
- Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12(Screening (Week -2), 4, 8 and 12)
- Clinical Global Impression-Improvement (CGI-I) Score(Week 4, 8 and 12)
- Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale(Baseline, Week 4, 8 and 12)
- Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12(Screening (Week -2), 4 and 12)