FOSCO Study (Functional Outcomes Study of OROS (Osmotic-controlled Release Oral Delivery System) Methylphenidate
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Purpose
The primary objective of this study is to evaluate the effectiveness at 12 weeks of the OROS Methylphenidate for children with Attention Deficit Hyperactivity Disorder (ADHD). The treatment effectiveness will be evaluated based upon the response and remission rate which are evaluated using the K-ARS (Korean ADHD Rating Scale) and CGI (Clinical Global Impression). The secondary objectives of this study are to assess changes in overall functioning in activities of daily living and social functioning and to examine the impact of symptomatic remission on functional changes and a casual relationship between remission and functional changes after administering OROS Methylphenidate in children and adolescents with ADHD.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: OROS methylphenidate hydrochloride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children With ADHD |
- Treatment effectiveness will be assessed by evaluating response rate defined as a decrease in total K-ARS (Korean ADHD Rating Scale) score by more than 25% and by evaluating the remission rate defined as total K-ARS score and CGI-S scale. [ Time Frame: K-ARS and CGI-S will be assessed at baseline (day 0), day 14, 28, 56 and 84 (end of trial) ] [ Designated as safety issue: No ]
- The changes in Child Health and Illness Profile-Child Edition (CHIP-CE) total and subdomains [ Time Frame: At every visit except visit 1 ] [ Designated as safety issue: No ]
- Comprehensive Attention Test (CAT) measures across the trial [ Time Frame: At visit 2 and 6 ] [ Designated as safety issue: No ]
- Academic Performance Rating Scale(APRS) [ Time Frame: At visit 2, 4 and 6 ] [ Designated as safety issue: No ]
- Beck Depression Inventory (BDI) [ Time Frame: At visit 2 and 6 ] [ Designated as safety issue: No ]
- Parenting Stress Index (PSI) [ Time Frame: At visit 2 and 6 ] [ Designated as safety issue: No ]
| Enrollment: | 140 |
| Study Start Date: | August 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
This is an open label (all people involved know the identity of the intervention), single arm, multicenter, prospective study evaluating the effectiveness of OROS (Osmotic-controlled Release Oral delivery System) methylphenidate for 12 weeks in treating children with Attention Deficit Hyperactivity Disorder (ADHD). Recently, the final aim of the treatment of ADHD goes beyond the stage of simple response to a drug and is being narrowed down to improvement in quality of life (QOL), day living (home and school life), functional recovery and the improvement of social relationships. Treatment effectiveness will be evaluated based upon response and remission rate. The secondary objectives are to examine how treatment with OROS Methylphenidate affects overall function and to determine the impact symptomatic remission has on changes in overall function. Adverse events will be reported during the study period. From the time point of starting the first procedure related to the study until the completion of all the study procedures, the investigator will follow up on any ongoing clinically significant abnormal results until stabilized or resolved. The study will assess safety and tolerability using the Symptom Rating Scale at every visit, clinical laboratory tests at visit 1, ECG at visit 1, vital signs/height/weight at first and last visit and physical exam at visit 1. The drug effect will be assessed by evaluating the improvement of subjects' ADHD symptoms before and after the treatment using the following standardized assessment surveys: Child Health and Illness Profile (CHIP), Korean ADHD Rating Scale (K-ARS), Clinical Global Impression of Severity (CGI-S) scale, Clinical Global Impression of Improvement (CGI-I) scale, Beck Depression Inventory (BDI), Parenting Stress Index (PSI), Comprehensive Attention Test (CAT) measures and academic performance. The patients will be on once daily study medication starting at 18 mg/day in children with less than 30 kg of body weight or at 27 mg/day in children with more than 30 kg. The dose is increased approximately every 7 days in 9 mg or 18 mg increments to 54 mg/day based on the clinical judgment of the investigator
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who voluntarily agreed to study participation
- Patients whose parent/legal representative signed voluntarily for the study participation
- Patient diagnosed as DSM-IV ADHD and judged to need a drug therapy
Exclusion Criteria:
- Being applicable to DSM-IV diagnosis criteria pertaining to main depression disorder or anxiety disorder and to need a drug therapy as of now
- Serious suicidal event history
- Mental retardation
- Bipolar disorder, mental disorder or drug abuse history, or diagnosis as overall developmental disorder, organic brain disease and epilepsy
- Tourettes disorder requiring drug therapy
- Taken OROS Methylphenidate (Concerta) within 3 months prior to screening
- Currently taking alpha-2 adrenergic receptor agonist, anti-depressant, anti-psychotic drug, benzodiazepine, modafinil, anticonvulsants or supplements which may affect central nervous system activity on the purpose of treating ADHD
Contacts and Locations More Information
No publications provided by Janssen Korea, Ltd., Korea
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01012622 History of Changes |
| Other Study ID Numbers: | CR015481, CON-KOR-4020 |
| Study First Received: | November 5, 2009 |
| Last Updated: | October 10, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Attention Deficit Hyperactivity Disorder Methylphenidate hydrochloride Functional outcome |
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 Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013