An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for Attention Deficit Hyperactivity Disorder (ADHD) and are considered to require medication therapy

• Participants that agreed to observe visit schedules and willingly complete the evaluation defined by participant (possibly to be completed by parents/guardians) during the treatment period

• Participants and parents/guardians that are able to understand the participation procedures of the research and spontaneously request the discontinuation therein at any time

• Participants that offered spontaneous consent for participation

• Participants whose guardian/legal representative provided spontaneous written consent

Exclusion Criteria:

• Hypersensitivity to methylphenidate HCl

• Participants diagnosed with major depression or anxiety disorders according to DSM-IV Diagnostic criteria and who requires drug therapy

• Participants with a history of bipolar disorder, psychotic disorder, and substance abuse disorder ordiagnosed with an overall developmental disorder, organic brain disorder, seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, movement disorder requiring the medication therapy, or with a family history of Tourette's syndrome (a neuropsychological disorder that causes marked distress or significant impairment in social, occupational, or other important areas of functioning)

• Taken Osmotic Release Oral System (OROS) Methylphenidate within 3 months prior to screening

• Currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant (drug used to stop seizures) or health food supplements that may have a central nervous system activity