Phase 4
Completed N=115
An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT01060150 ↗
Enrolled (actual)
115
Serious AEs
1.8%
Results posted
Jul 2013
Primary outcomePrimary: Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score — 11.78 Units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score |
11.78 | — |
| PRIMARY Clinical Global Impression - Severity (CGI-S) Score |
2.81 | — |
| PRIMARY Clinical Global Impression - Improvement (CGI-I) Score |
2.14 | — |
| PRIMARY Learning Skill Test (LST) Total Score |
49.61 | — |
| SECONDARY Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors |
58.88; 57.40; 62.98; 51.70 | — |
| SECONDARY Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability |
54.32; 49.73; 85.77; 59.42 | — |
| SECONDARY Digit Span Test Score |
11.19; 11.56; 7.09; 7.32 | — |
| SECONDARY Finger Window (FW) Test Score |
18.42; 19.09; 15.59; 17.36 | — |
| SECONDARY Controlled Oral Words Association Test (COWAT) Score |
29.71; 30.62; 28.71; 33.78 | — |
| SECONDARY Stroop Test Result for Reaction Time |
14.78; 13.64; 15.88; 15.04; 22.12; 19.72 | — |
| SECONDARY Stroop Test Result for False Reaction |
0.4; 0.16; 0.3; 0.2; 1.04; 0.84 | — |
| SECONDARY Stroop Test Score for Ratio Interference |
0.70; 0.72 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01060150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.