Back to resultsA Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Primary Purpose
Autism, Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate Transdermal System
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, Autism Spectrum Disorders, ADHD
Eligibility Criteria
Inclusion Criteria:
- Between 6 and 11 years
- Autism Spectrum Disorder
- Attention Deficit Hyperactivity Disorder
- Stimulant medication-free at study entry
- No clinically significant abnormalities that preclude safe participation
- Sufficient developmental level (~3 yrs)
- Able to keep appointments
- Able to communicate effectively
- Teacher cooperation
Exclusion Criteria:
- Received an investigational medication in the previous 30 days
- Current medication treatment is effective and well-tolerated
- Medical conditions that affect patient safety
- MAOIs within one month
- Hypertension
- Bipolar disorder or psychosis
- Anticonvulsants
- Psychotropic medication or health food supplement
- Tourette Disorder
- Seizure disorder
- Neurological condition
- Structural heart disease
Sites / Locations
- OU Child Study Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methylphenidate Transdermal System
Arm 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
Outcomes
Primary Outcome Measures
Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
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.
Secondary Outcome Measures
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
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).
Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
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).
Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
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).
Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
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).
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
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).
Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
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.
Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
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.
Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
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.
Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
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.
Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
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.
Full Information
NCT ID
NCT00541346
First Posted
October 8, 2007
Last Updated
December 19, 2013
Sponsor
University of Oklahoma
Collaborators
Mark L. Wolraich, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00541346
Brief Title
A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Official Title
Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Mark L. Wolraich, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed.
The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.
Detailed Description
The design will be an open-label trial of eight weeks duration with 20 children with Autism co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. After each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Attention Deficit Hyperactivity Disorder
Keywords
Autism, Autism Spectrum Disorders, ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate Transdermal System
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Transdermal System
Other Intervention Name(s)
Daytrana, MethylPatch, MTS
Intervention 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
Primary Outcome Measure Information:
Title
Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
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
Secondary Outcome Measure Information:
Title
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
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
Title
Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
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
Title
Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
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
Title
Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
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
Title
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
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
Title
Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
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
Title
Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
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
Title
Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
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
Title
Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
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
Title
Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 6 and 11 years
Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Stimulant medication-free at study entry
No clinically significant abnormalities that preclude safe participation
Sufficient developmental level (~3 yrs)
Able to keep appointments
Able to communicate effectively
Teacher cooperation
Exclusion Criteria:
Received an investigational medication in the previous 30 days
Current medication treatment is effective and well-tolerated
Medical conditions that affect patient safety
MAOIs within one month
Hypertension
Bipolar disorder or psychosis
Anticonvulsants
Psychotropic medication or health food supplement
Tourette Disorder
Seizure disorder
Neurological condition
Structural heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Lock, M.D.
Organizational Affiliation
OU Child Study Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark L Wolraich, M.D.
Organizational Affiliation
OU Child Study Center
Official's Role
Study Director
Facility Information:
Facility Name
OU Child Study Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16080422
Citation
Abanilla PK, Hannahs GA, Wechsler R, Silva RR. The use of psychostimulants in pervasive developmental disorders. Psychiatr Q. 2005 Fall;76(3):271-81. doi: 10.1007/s11126-005-2980-7.
Results Reference
background
Learn more about this trial
A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
We'll reach out to this number within 24 hrs