Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)
关键词
抽象
描述
This is an Observational, survey study. The survey is designed to be administered in two stages. In the first stage, patients who were prescribed Immediate-Released Methylphenidate (IR-MPH) for over 3 months, who are also on IR-MPH 1 month prior and who meet inclusion criteria will be enrolled. On survey day 1, the patients, parents/caregivers, and clinicians will assess patient drug compliance. For patients considered non-compliant, the Investigator will decide whether or not to change current medication. Those patients whose medication is changed from IR-MPH to another treatment for ADHD, will be enrolled into the second stage. On survey day 1, Clinical Global Impression (CGI) and the effects of the medication on sleep quality, decreased appetite, dizziness and or headache, and gastrointestinal upset will be assessed based on clinical interview. Any other side effects shown during medication treatment will be also recorded in the first stage. Parent/Caregivers will need to complete the Swanson, Nolan and Pelham (SNAP) Questionnaire which will evaluate the ADHD child's symptoms of inattention, hyperactivity, impulsivity and oppositional defiant disorder. In the second stage, those ADHD patients who meet the definition of non-compliance will be treated with other medications for over three weeks. On the first visit back after starting treatment with other medications, drug compliance, CGI, any change in negative parent-child interaction, overall classroom behavior, overall academic performance, the effects on sleep quality, decreased appetite, diziness and or headache, and gastrointestinal upset will be assessed by Investigator interview. Parent/Caregivers will need to complete SNAP Questionaire which will evaluate the ADHD child's symptoms of inattention, hyperactivity, impulsivity and oppositional defiant disorder. It is a survey type of study. No study drug has been used in the study.
日期
| 最后验证: | 03/31/2010 |
| 首次提交: | 04/12/2007 |
| 提交的预估入学人数: | 04/12/2007 |
| 首次发布: | 04/15/2007 |
| 上次提交的更新: | 04/25/2010 |
| 最近更新发布: | 04/27/2010 |
| 预计完成日期: | 01/31/2006 |
状况或疾病
干预/治疗
Other: 001
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 001 | Other: 001 Observational treatment compliance survey |
资格标准
| 有资格学习的年龄 | 6 Years 至 6 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patients with a clinical diagnosis of DSM-IV ADHD - Patients were previously treated with Immediate-Released Methylphenidate (IR-MPH) taken once a day, twice a day, three times a day, or four times a day over three months and who were also on IR-MPH the last month without severe adverse events or possible contraindications with MPH - Patients whose parent or guardian has signed and dated an informed consent to participate in the survey of drug compliance - Patients who are still at school Exclusion Criteria: - ADHD patients who have systematic disease or clinically significant gastrointestinal problems, including narrowing (pathologic or iatrogenic) of the gastrointestinal tract - ADHD patients also diagnosed with psychosis except for Conduct Disorder and Oppositional Defiant Disorder |
结果
主要结果指标
1. The change from survey day 1 to first visit in Clinical Global Impression score [3 weeks]
次要成果指标
1. The change from baseline in Swanson, Nolan and Pelham (SNAP) Questionnaire. [3 weeks]
