Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory (CHOP)
This study has been completed.
Sponsor:
Children's Hospital of Philadelphia
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00530257
First received: September 13, 2007
Last updated: November 15, 2011
Last verified: November 2011
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Results First Received: March 29, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Attention Deficit Hyperactivity Disorder |
| Interventions: |
Drug: Placebo Drug: OROS-methylphenidate |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were recruited from an outpatient ADHD evaluation and treatment program at a pediatric academic medical center. Eligible children wer: 1) Age 6-12 years and at least in 1st grade; 2) DSM-IVTR diagnosis of ADHD, Combined Type;3) Parent and teacher ratings on the ADHD Rating Scale-IV > 85th percentile; 5) IQ greater than 75 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Parents of 41 patients inquired about participating in the study. Four did not meet eligibility requirements leaving 37 eligible children. Three families elected not to participate leaving 34 children. Three children did not complete the dose finding stage leaving 31 children who entered the double blind placebo controlled crossover study. |
Reporting Groups
| Description | |
|---|---|
| OROS Methylphenidate | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below. |
Participant Flow: Overall Study
| OROS Methylphenidate | |
|---|---|
| STARTED | 31 |
| COMPLETED | 30 |
| NOT COMPLETED | 1 |
| Lost to Follow-up | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| OROS Methylphenidate | Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below. |
Baseline Measures
| OROS Methylphenidate | |
|---|---|
|
Number of Participants
[units: participants] |
30 |
|
Age
[units: participants] |
|
| <=18 years | 30 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
8.5 ± 1.9 |
|
Gender
[units: participants] |
|
| Female | 6 |
| Male | 24 |
|
Region of Enrollment
[units: participants] |
|
| United States | 30 |
Outcome Measures
| 1. Primary: | Test of Everyday Attention for Children: Walk, Don't Walk [ Time Frame: 2 weeks ] |
| 2. Primary: | Gordon Diagnostic System Continuous Performance Test [ Time Frame: 2 weeks ] |
| 3. Primary: | Wechsler Intelligence Scale for Children-IV, Digit Span Subtest [ Time Frame: 2 weeks ] |
| 4. Primary: | Test of Everyday Attention for Children-Sky Search Dual Task [ Time Frame: 2 weeks ] |
| 5. Primary: | Test of Everyday Attention for Children: Score Dual Task (DT) [ Time Frame: 2 weeks ] |
| 6. Primary: | Test of Everyday Attention for Children: Creature Counting [ Time Frame: 2 weeks ] |
| 7. Primary: | Test of Everyday Attention for Children: Map Mission [ Time Frame: 2 weeks ] |
| 8. Primary: | Test of Everyday Attention for Children: Sky Search [ Time Frame: 2 weeks ] |
| 9. Primary: | Test of Everyday Attention for Children: Opposite Worlds [ Time Frame: 2 weeks ] |
| 10. Secondary: | Behavior Rating Inventory of Executive Function [ Time Frame: 2 Weeks ] |
| 11. Secondary: | ADHD Rating Scale-IV, Parent and Teacher Version [ Time Frame: 2 Weeks ] |
| 12. Other Pre-specified: | Stimulant Side Effect Rating Scale [ Time Frame: 2 weeks ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Dr. Nathan Blum
Organization: The Children's Hospital of Philadelphia
phone: 215-590-6336
e-mail: blum@email.chop.edu
Organization: The Children's Hospital of Philadelphia
phone: 215-590-6336
e-mail: blum@email.chop.edu
No publications provided
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00530257 History of Changes |
| Other Study ID Numbers: | 2004-3-3588 |
| Study First Received: | September 13, 2007 |
| Results First Received: | March 29, 2011 |
| Last Updated: | November 15, 2011 |
| Health Authority: | United States: Institutional Review Board |