Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

NCT00460720 | Completed

• 1 other identifier: CR013384
• Study Type: observational
• Target: 591
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; Methylphenidate; MPH; Extended-Release Methylphenidate

Outcome Measures

Primary Outcomes (1)

• The change from survey day 1 to first visit in Clinical Global Impression score

  3 weeks

Secondary Outcomes (1)

• The change from baseline in Swanson, Nolan and Pelham (SNAP) Questionnaire.

  3 weeks

Study Arms (1)

001

Other: Observational treatment compliance survey

Interventions

Observational treatment compliance survey OTHER

Observational treatment compliance survey

001

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

Related Publications (2)

• Chou WJ, Chou MC, Tzang RF, Hsu YC, Gau SS, Chen SJ, Wu YY, Huang YF, Liang HY, Cheng H. Better efficacy for the osmotic release oral system methylphenidate among poor adherents to immediate-release methylphenidate in the three ADHD subtypes. Psychiatry Clin Neurosci. 2009 Apr;63(2):167-75. doi: 10.1111/j.1440-1819.2009.01937.x.

  PMID: 19335386 DERIVED

• Gau SS, Chen SJ, Chou WJ, Cheng H, Tang CS, Chang HL, Tzang RF, Wu YY, Huang YF, Chou MC, Liang HY, Hsu YC, Lu HH, Huang YS. National survey of adherence, efficacy, and side effects of methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan. J Clin Psychiatry. 2008 Jan;69(1):131-40. doi: 10.4088/jcp.v69n0118.

  PMID: 18312048 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Completion: February 1, 2006
• Last Updated: April 28, 2010

Record last verified: 2010-04