Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178503
Status:
COMPLETED
Last Update Posted:
2013-05-09
First Post:
2005-09-12
Brief Title:
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
ADHD Symptoms in Autism Cognition Behavior Treatment
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examined the cognitive and behavioral differences in children who have an autism spectrum disorder ASD with or without additional symptoms of ADHD The study also examined the effectiveness of a range of doses of methylphenidate in improving cognitive and behavioral outcomes in children with both ASD and ADHD
Detailed Description:
Attention Deficit Hyperactivity Disorder ADHD is a major comorbid psychiatric disorder in children with Autism Spectrum Disorders ASD that significantly undermines behavioral social and emotional adjustment Although the Diagnostic and Statistical Manual of Mental Disorders DSM-IV does not specifically allow for a comorbid diagnosis of ADHD with ASD many children with an ASD manifest symptoms of ADHD and are treated for it with stimulants or other medication The few studies on ADHD in ASD have not consistently established its cognitive and behavioral manifestations or the optimal parameters for treatment The proposed project will address these issues through studies of cognitive and behavioral functioning in children with ASD with and without ADHD and through a study of medication treatment of ADHD symptoms in autism
Participants between the ages of 7 to 12 with an autism spectrum disorder participated in the initial phase of the study to examine the nature and effects of ADHD symptoms on behavioral and cognitive functioning Participants underwent an initial psychological testing session that included standardized measures of intellectual adaptive behavior language behavioral and emotional functioning along with standardized diagnostic measures to confirm their diagnoses of ASD andor ADHD Visit 1 Children with intelligence quotients IQs below 50 or greater than 130 or with major sensory motor neurological genetic or psychiatric disorders that may interfere with testing were be excluded The participants who meet eligibility criteria completed computerized tasks of attentional functioning in a second visit Visit 2
A subset of the children meeting criteria for the ASDADHD group N24 participated in a six-week randomized double-blind placebo-controlled treatment trial using various doses low medium or high dose of methylphenidate MPH Children participated in the treatment trial will be those who qualified based on the initial phase and who do not have any physical contraindications to MPH eg history of MPH intolerance In each week of the treatment trial the children took one of the three doses of MPH or a placebo At the end of each week the child were evaluated in the clinic by including a medical check-up parent interviews about the childs behavior and functioning that week and computerized cognitive testing Additionally the childs parent and teacher completed questionnaires about the childs behavior each week so that the childs home and school behaviors at each MPH dose could be assessed
Participants between the ages of 7 to 12 with an autism spectrum disorder participated in the initial phase of the study to examine the nature and effects of ADHD symptoms on behavioral and cognitive functioning Participants underwent an initial psychological testing session that included standardized measures of intellectual adaptive behavior language behavioral and emotional functioning along with standardized diagnostic measures to confirm their diagnoses of ASD andor ADHD Visit 1 Children with intelligence quotients IQs below 50 or greater than 130 or with major sensory motor neurological genetic or psychiatric disorders that may interfere with testing were be excluded The participants who meet eligibility criteria completed computerized tasks of attentional functioning in a second visit Visit 2
A subset of the children meeting criteria for the ASDADHD group N24 participated in a six-week randomized double-blind placebo-controlled treatment trial using various doses low medium or high dose of methylphenidate MPH Children participated in the treatment trial will be those who qualified based on the initial phase and who do not have any physical contraindications to MPH eg history of MPH intolerance In each week of the treatment trial the children took one of the three doses of MPH or a placebo At the end of each week the child were evaluated in the clinic by including a medical check-up parent interviews about the childs behavior and functioning that week and computerized cognitive testing Additionally the childs parent and teacher completed questionnaires about the childs behavior each week so that the childs home and school behaviors at each MPH dose could be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH072263 | NIH | None | None |
| DDTR B2-NDA | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH072263 |