Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
Attention Deficit Disorder With Hyperactivity, Methylphenidate, Concerta
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.
Interventions
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.
Sponsors
Johnson & Johnson Taiwan Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8 | Baseline and 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. |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Baseline and 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 | Baseline and 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 | Baseline and 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 | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Baseline, Week 2, 4 and 8 | 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 | Baseline, Week 2, 4 and 8 | 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. |
| Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Baseline, Week 4 and 8 | 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 | Baseline, Week 2, 4 and 8 | 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) | Baseline, Week 4 and Week 8 | 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 | Baseline, Week 2, 4 and 8 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Satisfaction by Participant | Baseline, Week 2, 4 and 8 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OROS MPH Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. | 296 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administration Problems | 3 |
| Overall Study | Adverse Event | 15 |
| Overall Study | Lack of Efficacy | 10 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | No Longer Requires Study Medication | 4 |
| Overall Study | Protocol Violation | 12 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | OROS MPH |
|---|---|
| Age, Continuous | 9.5 Years STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 247 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 80 / 296 | 100 / 296 | 90 / 296 | 95 / 296 |
| serious Total, serious adverse events | 0 / 296 | 0 / 296 | 0 / 296 | 0 / 296 |
Outcome results
Primary
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.
Time frame: Baseline and Week 4
Population: ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 | Baseline: Mother Assessment (n = 275) | 1.9 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 | Baseline: Father Assessment (n = 216) | 1.7 Units on a scale | Standard Deviation 0.4 |
| OROS MPH | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 | Change at Week 4: Mother Assessment (n = 275) | -0.1 Units on a scale | Standard Deviation 0.4 |
| OROS MPH | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 | Change at Week 4: Father Assessment (n = 216) | 0 Units on a scale | Standard Deviation 0.3 |
Primary
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.
Time frame: Baseline and Week 8
Population: ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8 | Change at Week 8: Mother Assessment (n = 275) | -0.1 Units on a scale | Standard Deviation 0.4 |
| OROS MPH | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8 | Change at Week 8: Father Assessment (n = 216) | 0 Units on a scale | Standard Deviation 0.4 |
Primary
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.
Time frame: Baseline and Week 2
Population: Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Baseline: Inattention (n = 293) | 1.7 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Baseline: Hyperactivity (n = 293) | 1.4 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Baseline: Oppositional (n = 296) | 1.3 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Change at Week 2: Inattention (n = 293) | -0.4 Units on a scale | Standard Deviation 0.5 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Change at Week 2: Hyperactivity (n = 293) | -0.3 Units on a scale | Standard Deviation 0.5 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Change at Week 2: Oppositional (n = 296) | -0.3 Units on a scale | Standard Deviation 0.5 |
Primary
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.
Time frame: Baseline and Week 4
Population: ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | Change at Week 4: Inattention (n = 293) | -0.4 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | Change at Week 4: Hyperactivity (n = 293) | -0.3 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | Change at Week 4: Oppositional (n = 296) | -0.3 Units on a scale | Standard Deviation 0.6 |
Primary
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.
Time frame: Baseline and Week 8
Population: ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 | Change at Week 8: Inattention (n = 293) | -0.5 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 | Change at Week 8: Hyperactivity (n = 293) | -0.4 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 | Change at Week 8: Oppositional (n = 296) | -0.4 Units on a scale | Standard Deviation 0.6 |
Secondary
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.
Time frame: Baseline, Week 4 and 8
Population: ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Baseline: Mother Assessment (n = 275) | 6.4 Units on a scale | Standard Deviation 2.9 |
| OROS MPH | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Baseline: Father Assessment (n = 216) | 6.5 Units on a scale | Standard Deviation 2.5 |
| OROS MPH | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Week 4: Mother Assessment (n = 280) | 6.6 Units on a scale | Standard Deviation 2.8 |
| OROS MPH | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Week 4: Father Assessment (n = 223) | 6.7 Units on a scale | Standard Deviation 2.5 |
| OROS MPH | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Week 8: Mother Assessment (n = 281) | 6.5 Units on a scale | Standard Deviation 3 |
| OROS MPH | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Week 8: Father Assessment (n = 226) | 6.6 Units on a scale | Standard Deviation 2.7 |
Secondary
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.
Time frame: Baseline, Week 2, 4 and 8
Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Clinical Global Impression-Severity (CGI-S) Score | Baseline (n = 290) | 4.3 Units on a scale | Standard Deviation 0.9 |
| OROS MPH | Clinical Global Impression-Severity (CGI-S) Score | Week 2 (n = 291) | 3.5 Units on a scale | Standard Deviation 1 |
| OROS MPH | Clinical Global Impression-Severity (CGI-S) Score | Week 4 (n = 291) | 3.1 Units on a scale | Standard Deviation 1.1 |
| OROS MPH | Clinical Global Impression-Severity (CGI-S) Score | Week 8 (n = 292) | 3.0 Units on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: Baseline, Week 2, 4 and 8
Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Global Assessment of Satisfaction by Parents/Caregivers | Baseline (n = 290) | 3.1 Units on a scale | Standard Deviation 0.9 |
| OROS MPH | Global Assessment of Satisfaction by Parents/Caregivers | Week 2 (n = 291) | 3.4 Units on a scale | Standard Deviation 0.8 |
| OROS MPH | Global Assessment of Satisfaction by Parents/Caregivers | Week 4 (n = 291) | 3.7 Units on a scale | Standard Deviation 0.8 |
| OROS MPH | Global Assessment of Satisfaction by Parents/Caregivers | Week 8 (n = 291) | 3.6 Units on a scale | Standard Deviation 0.9 |
Secondary
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).
Time frame: Baseline, Week 2, 4 and 8
Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 8: No change (n = 282) | 28 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 2: Very much improved (n = 292) | 4 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 2: Much improved (n = 292) | 98 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 2: Minimally improved (n = 292) | 126 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 2: No change (n = 292) | 45 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 2: Minimally worse (n = 292) | 16 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 2: Much worse (n = 292) | 2 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 2: Very much worse (n = 292) | 1 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 4: Very much improved (n = 262) | 15 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 4: Much improved (n = 262) | 111 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 4: Minimally improved (n = 262) | 96 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 4: No change (n = 262) | 27 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 4: Minimally worse (n = 262) | 10 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 4: Much worse (n = 262) | 3 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 4: Very much worse (n = 262) | 0 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 8: Very much improved (n = 282) | 16 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 8: Much improved (n = 282) | 129 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 8: Minimally improved (n = 282) | 91 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 8: Minimally worse (n = 282) | 13 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 8: Much worse (n = 282) | 4 Participants |
| OROS MPH | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Week 8: Very much worse (n = 282) | 1 Participants |
Secondary
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.
Time frame: Baseline, Week 4 and Week 8
Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Social Adjustment Scale Score for Children and Adolescents (SAICA) | Baseline (n = 151) | 1.5 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Social Adjustment Scale Score for Children and Adolescents (SAICA) | Week 4 (n = 160) | 1.8 Units on a scale | Standard Deviation 0.3 |
| OROS MPH | Social Adjustment Scale Score for Children and Adolescents (SAICA) | Week 8 (n = 165) | 1.8 Units on a scale | Standard Deviation 0.3 |
Secondary
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.
Time frame: Baseline, Week 2, 4 and 8
Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Baseline: Inattention (n = 281) | 1.5 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Baseline:Hyperactivity (n = 285) | 1.1 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Baseline: Oppositional (n = 283) | 0.9 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 2: Inattention (n = 286) | 1.3 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 2: Hyperactivity (n = 287) | 0.9 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 2: Oppositional (n = 286) | 0.7 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 4: Inattention (n = 287) | 1.2 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 4: Hyperactivity (n = 288) | 0.9 Units on a scale | Standard Deviation 0.8 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 4: Oppositional (n = 287) | 0.7 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 8: Inattention (n = 287) | 1.1 Units on a scale | Standard Deviation 0.6 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 8: Hyperactivity (n = 288) | 0.8 Units on a scale | Standard Deviation 0.7 |
| OROS MPH | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Week 8: Oppositional (n = 287) | 0.7 Units on a scale | Standard Deviation 0.7 |
Other Pre-specified
Global Assessment of Satisfaction by Participant
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
Population: ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS MPH | Global Assessment of Satisfaction by Participant | Baseline (n = 290) | 3.2 Units on a scale | Standard Deviation 0.9 |
| OROS MPH | Global Assessment of Satisfaction by Participant | Week 2 (n = 291) | 3.5 Units on a scale | Standard Deviation 0.8 |
| OROS MPH | Global Assessment of Satisfaction by Participant | Week 4 (n = 291) | 3.7 Units on a scale | Standard Deviation 0.8 |
| OROS MPH | Global Assessment of Satisfaction by Participant | Week 8 (n = 291) | 3.6 Units on a scale | Standard Deviation 0.9 |