NCT00178503|CompletedPhase 2/3ResultsDMC
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
ADHD Symptoms in Autism: Cognition, Behavior, Treatment
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
24
1 country
1
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 15, 2005
Actual (reported)May 2011
Actual (reported)May 2011
Actual (reported)May 7, 2013
Actual (reported)Mean Conners' Teacher ADHD Index T Score by Dose
The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.
Measured at each dosing week of the drug trial (placebo, low, medium, high)
Mean Continuous Performance Test (CPT)-Commission Errors by Dose
CPT is a measure of sustained attention using nonverbal stimuli (pictures). Participants are asked to click on the witch (target), which appears for 25% of the trials. Commission errors are measured by number of times they click for the non-target items.
Measured at each dosing week of the drug trial (placebo, low, medium, high)
Mean Conners' Parent ADHD Index T Score by Week
Measured at each dosing week of the drug trial (placebo, low, medium, high)
24 Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
24 Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
Methylphenidate-extended release was taken in the morning of the MPH treatment trial. Each participant underwent 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 10 mg Ritalin LA to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took from 10 mg Ritalin LA to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 20 mg Ritalin LA to 40 mg.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Methylphenidate-extended release
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordFormulated product
Methylphenidate-immediate release
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordUniversity of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
We did not have teacher behavioral data for all of the children because some of them were seen during the summer, when teacher input was not available.
Deborah A. Pearson, PhD
The University of Texas Health Science Center, Houston
24 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
24 Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
24 Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
Methylphenidate-immediate release was taken in the late afternoon. Each participant underwent 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) took 2.5 mg IR-MPH and 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) took 2 weeks of 5 mg IR-MPH and 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) took 1 week of 5 mg IR-MPH and 2 weeks of 10 mg.
Participants will take a placebo for 1 full week of the randomized drug trial. They will take one capsule in the morning and one capsule in the afternoon.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
May 9, 2013
Results First Posted
May 7, 2013
Record last verified: 2013-05
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Source: ClinicalTrials.gov.
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