Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Taiwan University Hospital |
---|---|
Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00598182 |
The objectives of this study are to investigate:
Condition |
---|
Attention Deficit Disorder With Hyperactivity |
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 |
Estimated Enrollment: | 64 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
Exclusion Criteria:
Contact: Susan Shur-Fen Gau, MD, PhD | +886-2-23123456 ext 66802 | gaushufe@ntu.edu.tw |
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 |
Principal Investigator: | Susan Shur-Fen Gau, MD, PhD | National Taiwan University Hospital |
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 |
Attention Deficit Disorder with Hyperactivity OROS methylphenidate |
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 |
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 |