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

NCT01060150 | Completed Phase 4 Results

• 3 other identifiers: CR015496CON-KOR-4019CONCERTAATT4082
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Hyperactivity Disorder; Methylphenidate hydrochloride; Methylphenidate; CONCERTA

Outcome Measures

Primary Outcomes (4)

• Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score

  The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.

  Week 12

• Clinical Global Impression - Severity (CGI-S) Score

  The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.

  Week 12

• Clinical Global Impression - Improvement (CGI-I) Score

  The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

  Week 12

• Learning Skill Test (LST) Total Score

  The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.

  Week 12

Secondary Outcomes (8)

• Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors

  Baseline and Week 12

• Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability

  Baseline and Week 12

• Digit Span Test Score

  Baseline and Week 12

• Finger Window (FW) Test Score

  Baseline and Week 12

• Controlled Oral Words Association Test (COWAT) Score

  Baseline and Week 12

Study Arms (1)

OROS Methylphenidate HCl

EXPERIMENTAL

Drug: OROS Methylphenidate HCl

Interventions

OROS Methylphenidate HCl DRUG

Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg will be given orally once daily up to Week 12.

Also known as: Concerta

OROS Methylphenidate HCl

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Related Publications (1)

• Na KS, Lee SI, Hong SD, Kim JH, Shim SH, Choi J, Yang J, Lee MS, Joung YS, Kim EJ, Park JH. Effect of osmotic-release oral system methylphenidate on learning skills in adolescents with attention-deficit/hyperactivity disorder: an open-label study. Int Clin Psychopharmacol. 2013 Jul;28(4):184-92. doi: 10.1097/YIC.0b013e3283612509.

  PMID: 23587983 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Research Director
• Organization: Medical Affairs / Janssen-Cil Korea

82-2-2094-4518

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: February 2, 2010
• Study Start: July 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 23, 2013
• Results First Posted: July 31, 2013

Record last verified: 2013-08