Attention Deficit Hyperactivity DisorderPhase 4CHOPNCT00530257
Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory
A Phase 4 study testing OROS-methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- OROS-methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type
- Parent and Teacher Ratings >85 percentile on inattention and/or hyperactivity/impulsivity scales
- Estimated Intelligence Quotient (IQ) > 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test
Who cannot join
- Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization, psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing of the gastrointestinal tract, or epilepsy
- Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation
- Use within 14-days of a monoamine oxidase inhibitor
- History of side effects on any methylphenidate preparation that required stopping the medication
- Inability to swallow a capsule or tablet
- Chronic treatment with coumarin, clonidine, or tricyclic antidepressants
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder
This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).
Read the detailed description
This study investigates the effect of Osmotic-Release Oral System (OROS)-methylphenidate, a long-acting stimulant, on multiple dimensions of attention and on working memory. Specifically, we will investigate the following two hypotheses: (1) OROS-methylphenidate will result in improved performance on measures assessing multiple domains of attention, including sustained attention, attentional control, selective attention, and divided attention, and (2) OROS-methylphenidate will result in improved performance on measures of working memory. In addition we will use the study to collect pilot data on whether the magnitude of the effect of OROS-methylphenidate varies across the different components of attention and working memory and whether improvement across any of these measures is helpful in predicting parent or teacher ratings of improvement.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Placebo, OROS-methylphenidate
- Keywords
- Attention Deficit Hyperactivity Disorder, Methylphenidate, Attention, Working Memory
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo (sugar pill)
OROS-methylphenidateDrug
Also called Concerta, Osmotic-Release Oral System -methylphenidate
18 mg to 54 mg once a day for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (sugar pill);Subjects will be equally randomized and will receive one week of treatment with placebo and compared to subjects who were randomized to receive one week of OROS-methylphenidate. Receives: Drug: Placebo |
| OROS-methylphenidate | Active comparator | Subjects will be equally randomized and will receive one week of treatment with the optimal dose of OROS methylphenidate compared with subjects randomized to receive one week of placebo. Receives: Drug: OROS-methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Everyday Attention for Children: Walk, Don't Walk
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don't Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.
Measured: 2 weeks
Gordon Diagnostic System Continuous Performance Test
This is a measure of sustained attention \& response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a "1" is followed by a "9". There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance.
Measured: 2 weeks
Wechsler Intelligence Scale for Children-IV, Digit Span Subtest
The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance.
Measured: 2 weeks
Test of Everyday Attention for Children-Sky Search Dual Task
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search Dual Task is a measure of sustained attention. Lower scores indicate better performance. There is not a finite range for this test and very high scores can be negative numbers.
Measured: 2 weeks
Test of Everyday Attention for Children: Score Dual Task (DT)
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.
Measured: 2 weeks
Test of Everyday Attention for Children: Creature Counting
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance.
Measured: 2 weeks
Test of Everyday Attention for Children: Map Mission
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.
Measured: 2 weeks
Test of Everyday Attention for Children: Sky Search
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance.
Measured: 2 weeks
Test of Everyday Attention for Children: Opposite Worlds
The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance..
Measured: 2 weeks
Secondary outcomes (2)
Behavior Rating Inventory of Executive Function
Measured: 2 Weeks
ADHD Rating Scale-IV, Parent and Teacher Version
This is the parent and teacher version of the ADHD Rating Scale-IV. The scale has 2 subscales, one for inattention and one for hyperactivity-impulsivity. The scores provided are percentile scores and can range from 1 to 99 percent. Higher scores indicate more problems in inattention or with hyperactivity-impulsivity
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startJun 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Nathan J Blum, M.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530257
- Sponsor's protocol ID
- 2004-3-3588
- Acronym
- CHOP
- Status last verified
- Nov 2011
- First submitted
- 13 Sep 2007
- Last updated
- 19 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00530257
- Acronym / sponsor ID
- CHOP / 2004-3-3588
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Methylphenidate, Attention, Working Memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Jun 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Posted 19 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).
Detailed description
This study investigates the effect of Osmotic-Release Oral System (OROS)-methylphenidate, a long-acting stimulant, on multiple dimensions of attention and on working memory. Specifically, we will investigate the following two hypotheses: (1) OROS-methylphenidate will result in improved performance on measures assessing multiple domains of attention, including sustained attention, attentional control, selective attention, and divided attention, and (2) OROS-methylphenidate will result in improved performance on measures of working memory. In addition we will use the study to collect pilot data on whether the magnitude of the effect of OROS-methylphenidate varies across the different components of attention and working memory and whether improvement across any of these measures is helpful in predicting parent or teacher ratings of improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (sugar pill);Subjects will be equally randomized and will receive one week of treatment with placebo and compared to subjects who were randomized to receive one week of OROS-methylphenidate. |
| OROS-methylphenidate | Active comparator | Drug: OROS-methylphenidateSubjects will be equally randomized and will receive one week of treatment with the optimal dose of OROS methylphenidate compared with subjects randomized to receive one week of placebo. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type
- Parent and Teacher Ratings >85 percentile on inattention and/or hyperactivity/impulsivity scales
- Estimated Intelligence Quotient (IQ) > 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test
Key exclusion criteria (6 listed)
- Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization, psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing of the gastrointestinal tract, or epilepsy
- Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation
- Use within 14-days of a monoamine oxidase inhibitor
- History of side effects on any methylphenidate preparation that required stopping the medication
- Inability to swallow a capsule or tablet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo (sugar pill) | Drug | Placebo |
| OROS-methylphenidateAlso: Concerta, Osmotic-Release Oral System -methylphenidate18 mg to 54 mg once a day for 1 week | Drug | OROS-methylphenidate |
Primary outcome
Test of Everyday Attention for Children: Walk, Don't Walk
Time frame: 2 weeks
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don't Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.
Gordon Diagnostic System Continuous Performance Test
Time frame: 2 weeks
This is a measure of sustained attention \& response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a "1" is followed by a "9". There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance.
Wechsler Intelligence Scale for Children-IV, Digit Span Subtest
Time frame: 2 weeks
The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance.
Test of Everyday Attention for Children-Sky Search Dual Task
Time frame: 2 weeks
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search Dual Task is a measure of sustained attention. Lower scores indicate better performance. There is not a finite range for this test and very high scores can be negative numbers.
Test of Everyday Attention for Children: Score Dual Task (DT)
Time frame: 2 weeks
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.
Test of Everyday Attention for Children: Creature Counting
Time frame: 2 weeks
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance.
Test of Everyday Attention for Children: Map Mission
Time frame: 2 weeks
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.
Test of Everyday Attention for Children: Sky Search
Time frame: 2 weeks
The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance.
Test of Everyday Attention for Children: Opposite Worlds
Time frame: 2 weeks
The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance..
2 secondary outcomes
Behavior Rating Inventory of Executive Function
Time frame: 2 Weeks
ADHD Rating Scale-IV, Parent and Teacher Version
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan J Blum, M.D. principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OROS-methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Everyday Attention for Children: Walk, Don't Walk (time frame: 2 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.