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
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance Survey of ADHD Medication for Optimal Satisfaction (COSMOS)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • The change from survey day 1 to first visit in Clinical Global Impression score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from baseline in Swanson, Nolan and Pelham (SNAP) Questionnaire. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 591
Study Completion Date: February 2006
Groups/Cohorts Assigned Interventions
001 Other: Observational treatment compliance survey
Observational treatment compliance survey

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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460720

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

No publications provided by Johnson & Johnson Taiwan Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Director, Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00460720     History of Changes
Other Study ID Numbers: CR013384
Study First Received: April 13, 2007
Last Updated: April 26, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:
Attention Deficit Hyperactivity Disorder
ADHD
Methylphenidate
MPH
Extended-Release Methylphenidate

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014