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A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

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ClinicalTrials.gov Identifier: NCT00541346
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Collaborator:
Mark L. Wolraich, M.D.
Information provided by (Responsible Party):
University of Oklahoma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Autism
Attention Deficit Hyperactivity Disorder
Intervention Drug: Methylphenidate Transdermal System
Enrollment 16

Recruitment Details 16 enrolled Study Start Date: September, 2007 Study Completion Date:May, 2009 Seen at OU Physician's Child Study Center.
Pre-assignment Details  
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Period Title: Baseline
Started 16
Completed 16
Not Completed 0
Period Title: Follow-up
Started 16
Completed 15
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
16
 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 16 participants
7.83  (1.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
2
  12.5%
Male
14
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
Hide Description This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ADHD-RS-IV Total Score 39.9  (7.7)
Follow-Up: ADHD-RS-IV Total Score 13.8  (9.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Posterior-Predictive Probability of Mean Change (Pre-Post) Score at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value 26.3
Confidence Interval (2-Sided) 95%
19.6 to 33.1
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
2.Secondary Outcome
Title Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
Hide Description The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ABC HYPERACTIVITY 34.1  (8.3)
Follow-up: ABC HYPERACTIVITY 11.3  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value 23.1
Confidence Interval (2-Sided) 95%
16.9 to 29.3
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
3.Secondary Outcome
Title Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
Hide Description The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems).
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ABC Irritability 19.8  (9.6)
Follow-up: ABC Irritability 9.1  (6.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value 10.9
Confidence Interval (2-Sided) 95%
5.4 to 16.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
Hide Description The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ABC Lethargy 11.3  (4.9)
Follow-up: ABC Lethargy 4.5  (3.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value 7.2
Confidence Interval (2-Sided) 95%
3.3 to 11.1
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
5.Secondary Outcome
Title Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
Hide Description The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems).
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ABC Stereotypy 5.6  (5.4)
Follow-up: ABC Stereotypy 1.3  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value 4.1
Confidence Interval 95%
1.2 to 6.9
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
6.Secondary Outcome
Title Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
Hide Description The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems).
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ABC Inappropriate Speech 5.5  (2.9)
Follow-up: ABC Inappropriate Speech 2.1  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian random intercept model.
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
1.8 to 5.2
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds
7.Secondary Outcome
Title Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
Hide Description The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning.
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: LPS Total 26.6  (9.0)
Follow-up: LPS Total 39.9  (12.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value -10.9
Confidence Interval (2-Sided) 95%
-16.8 to -5.4
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds
8.Secondary Outcome
Title Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
Hide Description The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported.
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: FAM-III Overall 55.7  (4.1)
Follow-up: FAM-III Overall 53.5  (5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.21
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value 1.94
Confidence Interval (2-Sided) 95%
-2.98 to 6.82
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
9.Secondary Outcome
Title Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
Hide Description The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area.
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: PEDI Self-Care 28.8  (7.0)
Follow-up: PEDI Self-Care 32.5  (6.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.06
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-7.9 to 0.80
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
10.Secondary Outcome
Title Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
Hide Description The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area.
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: PEDI Social Function 9.3  (5.0)
Follow-up: PEDI Social Function 14.9  (5.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value -5.26
Confidence Interval (2-Sided) 95%
-9.37 to -1.18
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
11.Secondary Outcome
Title Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
Hide Description This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Time Frame Baseline, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description:
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: ADHDRS Teacher Total 32.6  (8.9)
Follow-up: ADHDRS Teacher Total 28.0  (14.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate Transdermal System
Comments Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.11
Comments Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.
Method Mixed Models Analysis
Comments Bayesian random intercept model.
Method of Estimation Estimation Parameter Bayesian Mean Change Score
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
-5.6 to 20.7
Estimation Comments The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate Transdermal System
Hide Arm/Group Description 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
All-Cause Mortality
Methylphenidate Transdermal System
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate Transdermal System
Affected / at Risk (%)
Total   1/16 (6.25%) 
Nervous system disorders   
tic  1  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Standard Terminology
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Methylphenidate Transdermal System
Affected / at Risk (%)
Total   14/16 (87.50%) 
Ear and labyrinth disorders   
earache  1  1/16 (6.25%) 
Eye disorders   
eyes bloodshot  1  1/16 (6.25%) 
itchy eyes  1  1/16 (6.25%) 
Gastrointestinal disorders   
Abdominal pain  1  1/16 (6.25%) 
vomiting  1  2/16 (12.50%) 
diarrhea  1  2/16 (12.50%) 
increased salivation  1  1/16 (6.25%) 
blood in stool  1  1/16 (6.25%) 
constipation  1  1/16 (6.25%) 
General disorders   
nose, inflammation of  1  1/16 (6.25%) 
Immune system disorders   
allergies  1  1/16 (6.25%) 
Infections and infestations   
fever  1  7/16 (43.75%) 
Metabolism and nutrition disorders   
appetite, loss of  1  3/16 (18.75%) 
Nervous system disorders   
Headache  1  3/16 (18.75%) 
Psychiatric disorders   
irritability  1  4/16 (25.00%) 
sleeping, difficulty  1  1/16 (6.25%) 
enuresis  1  1/16 (6.25%) 
less social  1  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Rhinitis Allergic  1  1/16 (6.25%) 
sore throat  1  1/16 (6.25%) 
congestion  1  1/16 (6.25%) 
rhinorrhea  1  4/16 (25.00%) 
nasal congestion  1  1/16 (6.25%) 
Skin and subcutaneous tissue disorders   
skin, dry  1  1/16 (6.25%) 
sores under nose  1  1/16 (6.25%) 
irritation 'burning' application site, patch  1  1/16 (6.25%) 
hives  1  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, standard Terminology
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Thomas M. Lock, M.D.
Organization: University of Oklahoma Health Sciences Center
Phone: 405-271-5700 ext 45167
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00541346     History of Changes
Other Study ID Numbers: SPD485-420-Lock
First Submitted: October 8, 2007
First Posted: October 10, 2007
Results First Submitted: November 15, 2010
Results First Posted: February 6, 2014
Last Update Posted: February 6, 2014