Trial · NCT00758160
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
NCT00758160, Phase 4, Completed, Johnson & Johnson Taiwan Ltd; results first posted 2014-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD). Trials, record NCT00758160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00758160
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
- NCT number
- NCT00758160
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 296 participants, actual
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- OROS Methylphenidate
- First posted
- 2008-09-23
- Last updated
- 2014-04-08
- Results first posted
- 2014-04-08
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | Baseline and Week 2 | 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. | Units on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | Baseline and Week 4 | 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. | Units on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 | Baseline and Week 8 | 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. | Units on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4 | Baseline and Week 4 | 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. | Units on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8 | Baseline and Week 8 | 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. | Units on a scale | MEAN |
| SECONDARY | Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score | Baseline, Week 4 and 8 | 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. | Units on a scale | MEAN |
| SECONDARY | Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score | Baseline, Week 2, 4 and 8 | 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. | Units on a scale | MEAN |
| SECONDARY | Social Adjustment Scale Score for Children and Adolescents (SAICA) | Baseline, Week 4 and Week 8 | 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. | Units on a scale | MEAN |
| SECONDARY | Clinical Global Impression-Severity (CGI-S) Score | Baseline, Week 2, 4 and 8 | 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. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score | Baseline, Week 2, 4 and 8 | 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. | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | OROS MPH | Baseline: Inattention (n = 293) | 1.7 | Standard Deviation 0.6 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | OROS MPH | Baseline: Hyperactivity (n = 293) | 1.4 | Standard Deviation 0.7 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | OROS MPH | Baseline: Oppositional (n = 296) | 1.3 | Standard Deviation 0.7 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | OROS MPH | Change at Week 2: Inattention (n = 293) | -0.4 | Standard Deviation 0.5 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | OROS MPH | Change at Week 2: Hyperactivity (n = 293) | -0.3 | Standard Deviation 0.5 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2 | OROS MPH | Change at Week 2: Oppositional (n = 296) | -0.3 | Standard Deviation 0.5 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | OROS MPH | Change at Week 4: Inattention (n = 293) | -0.4 | Standard Deviation 0.6 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | OROS MPH | Change at Week 4: Hyperactivity (n = 293) | -0.3 | Standard Deviation 0.6 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4 | OROS MPH | Change at Week 4: Oppositional (n = 296) | -0.3 | Standard Deviation 0.6 | Units on a scale |
| Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8 | OROS MPH | Change at Week 8: Inattention (n = 293) | -0.5 | Standard Deviation 0.6 | Units on a scale |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OROS MPH | 296 | |
| Overall Study | COMPLETED | OROS MPH | 230 | |
| Overall Study | NOT COMPLETED | OROS MPH | 66 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Appetite decreased | General disorders | OROS MPH-Baseline | 80 | 296 | |
| other | Appetite decreased | General disorders | OROS MPH-Week 2 | 100 | 296 | |
| other | Appetite decreased | General disorders | OROS MPH-Week 4 | 90 | 296 | |
| other | Appetite decreased | General disorders | OROS MPH-Week 8 | 95 | 296 | |
| other | Nausea | General disorders | OROS MPH-Baseline | 22 | 296 | |
| other | Nausea | General disorders | OROS MPH-Week 2 | 22 | 296 | |
| other | Nausea | General disorders | OROS MPH-Week 4 | 15 | 296 | |
| other | Nausea | General disorders | OROS MPH-Week 8 | 15 | 296 | |
| other | Insomnia | General disorders | OROS MPH-Baseline | 22 | 296 | |
| other | Insomnia | General disorders | OROS MPH-Week 2 | 35 | 296 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OROS MPH-Baseline | ||
| Total, all-cause mortality | OROS MPH-Week 2 | ||
| Total, all-cause mortality | OROS MPH-Week 4 | ||
| Total, all-cause mortality | OROS MPH-Week 8 | ||
| Total, other adverse events | OROS MPH-Baseline | 80 | 296 |
| Total, other adverse events | OROS MPH-Week 2 | 100 | 296 |
| Total, other adverse events | OROS MPH-Week 4 | 90 | 296 |
| Total, other adverse events | OROS MPH-Week 8 | 95 | 296 |
| Total, serious adverse events | OROS MPH-Baseline | 0 | 296 |
| Total, serious adverse events | OROS MPH-Week 2 | 0 | 296 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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