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CompletedNCT00460720Updated Apr 28, 2010

Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

An observational study in Attention Deficit Disorder With Hyperactivity, sponsored by Johnson & Johnson Taiwan Ltd. Completed. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2010-04-28.

Sponsored by Johnson & Johnson Taiwan Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
591
Ages
6 Years to 16 Years
Sex
All
01

Study 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

Read the detailed 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.

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity

Keywords

  • Attention Deficit Hyperactivity Disorder
  • ADHD
  • Methylphenidate
  • MPH
  • Extended-Release Methylphenidate
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 591 is above the median of 134 across 122 observational studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Johnson & Johnson Taiwan Ltd is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
591 participants (actual)

Groups and cohorts

  • 001

    Other: Observational treatment compliance survey

Interventions

  • OtherObservational treatment compliance survey

    Observational treatment compliance survey

06

What researchers measure

Primary outcomes

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

    Time frame: 3 weeks

Secondary outcomes

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

    Time frame: 3 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19335386 ↗
  • 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. PubMed 18312048 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00460720
Lead sponsor
Johnson & Johnson Taiwan Ltd
First posted
Apr 16, 2007
Completion
Feb 2006
Last update
Apr 28, 2010

Study contacts

Johnson & Johnson Taiwan, Ltd. Clinical Trial
study director · Johnson & Johnson Taiwan Ltd
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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