Back to resultsThe Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
OROS Methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention Deficit Disorder With Hyperactivity, Methylphenidate, Concerta
Eligibility Criteria
Inclusion Criteria:
- Participants who are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Participants who have been treated with Immediate-release methyphenidate (IR-MPH) for at least 4 weeks before enrollment, but previous treatment is considered unsatisfactory due to 1 or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance, and/or other reasons
- Participants who are able to comply with the study visit schedule and whose parents/caregiver and community school teacher are willing and able to complete the protocol-specified assessments
- Participants who are still at school
- Participants who are treated with greater than equal to 10 milligram (mg) IR-MPH daily before enrollment
Exclusion Criteria:
- Participants who cannot understand or follow the instructions given in the study
- Participants with serious or unstable medical illness
- Participants who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
- Participants who have glaucoma (increased pressure inside the eye that causes visual problems), an ongoing seizure disorders, or a psychotic disorder
- Participants who are hypersensitive to methylphenidate
- Participants who have any co-existing medical condition or are taking a concomitant medication that is likely to interfere with safe administration of methylphenidate
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OROS methylphenidate
Arm Description
Participants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.
Secondary Outcome Measures
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.
Social Adjustment Scale Score for Children and Adolescents (SAICA)
SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children's current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.
Clinical Global Impression-Severity (CGI-S) Score
CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).
Global Assessment of Satisfaction by Parents/Caregivers
Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.
Full Information
NCT ID
NCT00758160
First Posted
September 19, 2008
Last Updated
March 10, 2014
Sponsor
Johnson & Johnson Taiwan Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00758160
Brief Title
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
From Immediate-release MPH to OROS MPH: The Impact Upon Family of Children and Adolescents With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Taiwan Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).
Detailed Description
This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. During the study period, participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ). Safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Disorder With Hyperactivity, Methylphenidate, Concerta
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OROS methylphenidate
Arm Type
Experimental
Arm Description
Participants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
Intervention Type
Drug
Intervention Name(s)
OROS Methylphenidate
Intervention Description
Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2
Description
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.
Time Frame
Baseline and Week 2
Title
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4
Description
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.
Time Frame
Baseline and Week 4
Title
Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8
Description
Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4
Description
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.
Time Frame
Baseline and Week 4
Title
Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8
Description
The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants' psychological problems (0-2=normal; 3-4=minor; 5-6=moderate; and 7-12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score
Description
Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.
Time Frame
Baseline, Week 4 and 8
Title
Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score
Description
Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.
Time Frame
Baseline, Week 2, 4 and 8
Title
Social Adjustment Scale Score for Children and Adolescents (SAICA)
Description
SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children's current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.
Time Frame
Baseline, Week 4 and Week 8
Title
Clinical Global Impression-Severity (CGI-S) Score
Description
CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.
Time Frame
Baseline, Week 2, 4 and 8
Title
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score
Description
CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician's total experience after reviewing all the returned questionnaires and clinical assessment of participants' behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).
Time Frame
Baseline, Week 2, 4 and 8
Title
Global Assessment of Satisfaction by Parents/Caregivers
Description
Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.
Time Frame
Baseline, Week 2, 4 and 8
Other Pre-specified Outcome Measures:
Title
Global Assessment of Satisfaction by Participant
Description
Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.
Time Frame
Baseline, Week 2, 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
Participants who have been treated with Immediate-release methyphenidate (IR-MPH) for at least 4 weeks before enrollment, but previous treatment is considered unsatisfactory due to 1 or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance, and/or other reasons
Participants who are able to comply with the study visit schedule and whose parents/caregiver and community school teacher are willing and able to complete the protocol-specified assessments
Participants who are still at school
Participants who are treated with greater than equal to 10 milligram (mg) IR-MPH daily before enrollment
Exclusion Criteria:
Participants who cannot understand or follow the instructions given in the study
Participants with serious or unstable medical illness
Participants who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
Participants who have glaucoma (increased pressure inside the eye that causes visual problems), an ongoing seizure disorders, or a psychotic disorder
Participants who are hypersensitive to methylphenidate
Participants who have any co-existing medical condition or are taking a concomitant medication that is likely to interfere with safe administration of methylphenidate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Taiwan, Ltd. Clinical Trial
Organizational Affiliation
Johnson & Johnson Taiwan Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
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