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Trial record 60 of 439 for:    Methylphenidate

Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory (CHOP)

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ClinicalTrials.gov Identifier: NCT00530257
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Placebo
Drug: OROS-methylphenidate
Enrollment 30
Recruitment Details 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 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.
Arm/Group Title OROS Methylphenidate
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 31
Completed 30
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title OROS Methylphenidate
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
30
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
8.5  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
6
  20.0%
Male
24
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Test of Everyday Attention for Children: Walk, Don't Walk
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
13.5
(0 to 20)
11
(0 to 19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of <=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen’s d= >0.655)
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Gordon Diagnostic System Continuous Performance Test
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
31 participants began the crossover phase of the trial and 30 completed both the medication and placebo arms. For one patient there was an equipment problem so that subject did not have data available
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 29 29
Median (Full Range)
Unit of Measure: errors
Omission Errors
2
(0 to 31)
4.5
(0 to 42)
Commission Errors
3
(1 to 143)
10.5
(0 to 164)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments Same as described for TEA-Ch Walk, Don't Walk
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Same as described for TEA-Ch Walk, Don't Walk
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Wechsler Intelligence Scale for Children-IV, Digit Span Subtest
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The 30 subjects who completed both arms of the crossover analysis
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
5.5
(0 to 10)
5.0
(3 to 9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments This p value is not adjusted for multiple comparisons
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Test of Everyday Attention for Children-Sky Search Dual Task
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
3.8
(-3.3 to 429)
3.9
(-0.3 to 101)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments Same as described for TEA-Ch: Walk, Don't Walk
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Same as described for TEA-Ch: Walk, Don't Walk.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Primary Outcome
Title Test of Everyday Attention for Children: Score Dual Task (DT)
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
14
(5 to 20)
13
(3 to 19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The p value adjusts for multiple comparisons
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Primary Outcome
Title Test of Everyday Attention for Children: Creature Counting
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
4.9
(3.1 to 12.8)
4.8
(3.1 to 28.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments Same as described for TEA-Ch: Walk, Don't Walk
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Same as described for TEA-Ch: Walk, Don't Walk
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Primary Outcome
Title Test of Everyday Attention for Children: Map Mission
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
27.5
(15 to 57)
27
(10 to 52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments Same as described for TEA-Ch: Walk, Don't Walk
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Same as described for TEA-Ch: Walk, Don't Walk
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Primary Outcome
Title Test of Everyday Attention for Children: Sky Search
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
5.8
(2.5 to 25.4)
4.5
(2.3 to 26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments Same as described for TEA-Ch: Walk, Don't Walk
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Same as described for TEA-Ch: Walk, Don't Walk
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Primary Outcome
Title Test of Everyday Attention for Children: Opposite Worlds
Hide Description 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..
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: units on a scale
38.5
(28 to 66)
47.5
(27 to 63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments Same as described for TEA-Ch: Walk, Don't Walk
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Same as described for TEA-Ch: Walk, Don't Walk
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Behavior Rating Inventory of Executive Function
Hide Description [Not Specified]
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Although this was included in the protocol we have not analyzed the results of this rating scale
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title ADHD Rating Scale-IV, Parent and Teacher Version
Hide Description 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
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
We had complete data for all 30 subjects for the parent rating scale. We only had 24 sets of complete data for the teacher rating scale as some teachers did not return a rating scale when the subject was on both medication and placebo
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Percentile
Parent Inattention Rating 70.6  (23.9) 92.6  (9.0)
Parent Hyperactivity-Impulsivity Rating 64.8  (26.5) 89.6  (13.1)
Teacher Inattention Rating 61.1  (23.2) 73.3  (19.9)
Teacher Hyperactivity-Impulsivity Rating 58.1  (22.1) 75.2  (19.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medication, Placebo
Comments A paired t-test was used to compare the medication versus placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments We did not correct for multiple comparisons
Method t-test, 2 sided
Comments We used a paired t-test
12.Other Pre-specified Outcome
Title Stimulant Side Effect Rating Scale
Hide Description Parents rate 16 possible stimulant side effects on a 10 point likert scale from 0-9 with 0 indicating no side effects and 9 indicating more severe symptoms.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medication Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Insomnia 2.8  (2.3) 1.2  (2.1)
Nightmares 0.3  (0.9) 0.2  (0.8)
Stares/Day Dreams 1.1  (1.7) 0.8  (1.3)
Talks less with others 1  (1.7) 0.4  (0.8)
Uninterested in others 0.8  (1.4) 0.3  (0.7)
Decreased appetite 3.4  (2.7) 1  (1.8)
Irritable 2.6  (2.4) 1.7  (1.9)
Stomachaches 1.5  (2.5) 0.5  (1.2)
Headaches 0.9  (1.8) 0.3  (0.9)
Drowsiness 0.9  (2.1) 0.3  (0.9)
Sad 1.6  (2) 1  (1.8)
Prone to Crying 2.2  (2.8) 1.4  (2.1)
Anxiety 2.3  (2.4) 1.8  (1.9)
Bites fingernails 1.3  (2.4) 0.5  (0.9)
Euphoric 0.5  (1.4) 0.3  (0.7)
Dizziness 0.1  (0.3) 0.04  (0.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OROS Methylphenidate Placebo
Hide Arm/Group Description 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 parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects. 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 parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
All-Cause Mortality
OROS Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OROS Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
OROS Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   20/31 (64.52%)   5/31 (16.13%) 
Gastrointestinal disorders     
decrease appetite  [1]  4/28 (14.29%)  1/28 (3.57%) 
Nervous system disorders     
Irritable  [2]  3/28 (10.71%)  1/28 (3.57%) 
stomachaches  [2]  2/28 (7.14%)  0/28 (0.00%) 
Headaches  [2]  1/28 (3.57%)  0/28 (0.00%) 
prone to crying  [2]  4/28 (14.29%)  1/28 (3.57%) 
Tics/Nervous movements  [2]  1/28 (3.57%)  0/28 (0.00%) 
Insomnia   2/28 (7.14%)  2/28 (7.14%) 
Psychiatric disorders     
Bites Fingernails  [2]  3/28 (10.71%)  0/28 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Score of 7-9 on rating scale
[2]
7-9 on rating scale
Certain Agreements
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nathan Blum
Organization: The Children's Hospital of Philadelphia
Phone: 215-590-6336
EMail: blum@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00530257     History of Changes
Other Study ID Numbers: 2004-3-3588
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: March 29, 2011
Results First Posted: December 19, 2011
Last Update Posted: December 19, 2011