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Adherence and Long-Term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, August 2008
First Received: January 9, 2008   Last Updated: August 31, 2008   History of Changes
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00598182
  Purpose

The objectives of this study are to investigate:

  1. the evolution of ADHD symptoms, remission rate of ADHD, social and school function, and familial relationship;
  2. the adherence to CONCERTA, treatment modality, and average treatment duration during the 3-year follow-up period; and
  3. the effect of medication on the changes of neuropsychological functioning.

Condition
Attention Deficit Disorder With Hyperactivity

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
Drug Information available for: Methylphenidate Methylphenidate hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only
Official Title: From Immediate-Release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD

Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 64
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Detailed Description:

Attention-deficit/hyperactivity disorder (ADHD) is a common impairing disease among children and adolescents. Methylphenidate, a stimulant, is effective in treating these patients. OROS methylphenidate (CONCERTA) provides ADHD patients a more convenient and safer treatment approach than immediate-release methylphenidate (IR-MPH). However, there is little information of long-term effect and adherence to CONCERTA. At the NTUH Taiwan, a randomized clinical trial of OROS MPH was performed 3 years ago and 64 subjects were included and treated with either IR MPH or OROS MPH followed by OROS MPH. Therefore, we purpose this study to follow up these patients, exploring the adherence rate to CONCERTA, symptoms evolution, and outcomes among these patients.

Overview of Study Design: There will be two stages of this study. All study procedures will be performed after obtaining informed consent.

Stage I: Medical charts of these subjects will be reviewed to obtain information about CONCERTA adherence (also including dosage, treatment duration, clinic visits, missing visits etc.), psychiatric co-morbidities, and other treatment approaches subjects received after the previous study. Subjects will be visited (Visit 1) and the information of baseline characteristics and reasons for discontinuing CONCERTA (if applicable) will be recorded. The assessments will included parent or teacher ratings on the Conner's Teacher and Parent Rating scales (CPRS-R:S, CTRS-R:S), the SNAP-IV rating scale, the SKAMP rating scale, investigator ratings on the Kiddie-SADS-E, Clinical Global Impression and the Social Adjustment Inventory for Children and Adolescents (SAICA); and neuropsychological assessments (Conner's Continuous Performance Test, CPT, and Cambridge Neuropsychological Test Automated Batteries, CANTA B) will be performed to these subjects. Stage II: All subjects enrolled into stage one will be followed for the next 6 months. Medication for ADHD treatment may be used to these subjects based on investigators' clinical judgments. Subjects will visit clinics in week-24 (Visit 2). The same assessments at Visit 1 will be performed at Visit 2. In addition, the adherence to treatment, adverse events, overall satisfaction to treatment, and academic performances during these 6 months will be recorded.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who were diagnosed as DSM-IV ADHD and participated in the randomized clinical trial for CONCERTA at NTUH Taiwan will be enrolled into this study.

Criteria

Inclusion Criteria:

  • Subjects who participated the randomized clinical trial for CONCERTA on NTUH.
  • Subjects whose parents/caregivers can complete the questionnaires during the study and can assist to finish the assessment properly during the study;
  • Subjects whose parent(s) or guardian(s) has signed and dated an informed consent for the subject to participate in the study.

Exclusion Criteria:

  • No.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598182

Contacts
Contact: Susan Shur-Fen Gau, MD, PhD +886-2-23123456 ext 66802 gaushufe@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Susan Shur-Fen Gau, MD, PhD     +886-2-23123456 ext 66802     gaushufe@ntu.edu.tw    
Principal Investigator: Susan Shur-Fen Gau, MD, PhD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital ( Susan Shur-Fen Gau )
Study ID Numbers: 200709022R, CCT-TWN-MA7
Study First Received: January 9, 2008
Last Updated: August 31, 2008
ClinicalTrials.gov Identifier: NCT00598182     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Attention Deficit Disorder with Hyperactivity
OROS methylphenidate

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009