Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460720
• Other study ID #: CR013384
• Status: Completed
• Phase: N/A
• First received: April 13, 2007
• Last updated: April 26, 2010
• Est. completion date: February 2006

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Taiwan Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Other:
• Observational treatment compliance survey
Observational treatment compliance survey

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Taiwan Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from survey day 1 to first visit in Clinical Global Impression score		3 weeks	No
Secondary	The change from baseline in Swanson, Nolan and Pelham (SNAP) Questionnaire.		3 weeks	No