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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Efficacy and Learning Skill After OROS Methylphenidate Treatment in Adolescents With Attention-Deficit/Hyperactivity Disorder: A 12-week, Multi-center, Open-label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060150
• Other study ID #: CR015496
• Secondary ID: CON-KOR-4019CONC
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2010
• Last updated: August 14, 2013
• Start date: July 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

This is 12 week, open label (all people involved know the identity of the intervention), prospective (study following participants forward in time), single arm, multicenter study (when more than one hospital or medical school team work on a medical research study) of OROS methylphenidate HCl. The study will consist of 6 visits at Screening, Baseline, Week 1, 3, 6 and 12. The participants already on other ADHD medications in addition to methylphenidate will be required to undergo a washout period (period when receiving no treatment) of at least 1 week. The participants will be on once daily study medication starting at 18 milligram per day (mg/day) in participants with less than 30 kilogram (kg) of body weight or at 27 mg/day in participants with more than 30 kg. The dose will be increased by 9 mg or 18 mg every week for up to Week 6 based on the treatment efficacy and tolerability, followed by a maximum maintenance dose of 72 mg orally once daily up to Week 12, during which the dose can be decreased by 9 mg depending on tolerability. Efficacy will primarily be assessed using Clinical Global Impression of Severity of Illness (CGI-S) scale, Clinical Global Impression of Improvement of Illness (CGI-I) scale, Korean version of ADHD-IV Rating Scale (K-ARS) and Learning Skill Test (LST) score. Participants' safety will be monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• OROS Methylphenidate HCl
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors	The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.	Baseline and Week 12	No
Secondary	Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability	The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor's score is over 65 point, the participant is resulted in having attention deficit.	Baseline and Week 12	No
Secondary	Digit Span Test Score	Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.	Baseline and Week 12	No
Secondary	Finger Window (FW) Test Score	In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.	Baseline and Week 12	No
Secondary	Controlled Oral Words Association Test (COWAT) Score	This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.	Baseline and Week 12	No
Secondary	Stroop Test Result for Reaction Time	This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.	Baseline and Week 12	No
Secondary	Stroop Test Result for False Reaction	This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.	Baseline and Week 12	No
Secondary	Stroop Test Score for Ratio Interference	Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.	Baseline and Week 12	No