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Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00460720
First received: April 13, 2007
Last updated: April 26, 2010
Last verified: April 2010

April 13, 2007
April 26, 2010
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The change from survey day 1 to first visit in Clinical Global Impression score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00460720 on ClinicalTrials.gov Archive Site
The change from baseline in Swanson, Nolan and Pelham (SNAP) Questionnaire. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)
Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

The survey is designed to identify non-compliant Attention Deficit Hyperactivity Disorder (ADHD) patients who are currently on Immediate- Released Methylphenidate (IR-MPH) and observe any change in compliance after treating with other drugs intended to treat ADHD for over 3 weeks

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients aged 6-16 years old with clinical diagnosis of DSM-IV ADHD

Attention Deficit Disorder With Hyperactivity
Other: Observational treatment compliance survey
Observational treatment compliance survey
001
Intervention: Other: Observational treatment compliance survey

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
591
February 2006
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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
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00460720
CR013384
Not Provided
Medical Director, Johnson & Johnson Taiwan Ltd
Johnson & Johnson Taiwan Ltd
Not Provided
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
Johnson & Johnson Taiwan Ltd
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP