Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598182
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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 or disease
Attention Deficit Disorder With Hyperactivity

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.

Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case-Only
Official Title: From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
Study Start Date : September 2007
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598182

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT00598182     History of Changes
Other Study ID Numbers: 200709022R
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents