Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
ADHD Symptoms in Autism: Cognition, Behavior, Treatment
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
May 7, 2013
CompletedMay 9, 2013
May 1, 2013
5.7 years
September 12, 2005
January 14, 2013
May 6, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Secondary Outcomes (1)
Mean Conners' Parent ADHD Index T Score by Week
Measured at each dosing week of the drug trial (placebo, low, medium, high)
Study Arms (4)
MPH Trial-Placebo
PLACEBO COMPARATOR24 Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
MPH Trial: Low Dose
ACTIVE COMPARATOR24 Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
MPH Trial: Med Dose
ACTIVE COMPARATOR24 Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
MPH Trial: High Dose
ACTIVE COMPARATOR24 Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Autism/ADHD Group:
- DSM-IV diagnosis of autistic disorder, as per the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS)
- Child manifests current symptoms of ADHD
- Autism/non-ADHD Group:
- Meets the diagnostic criteria for autism, as above, but does not meet the diagnostic criteria for ADHD
You may not qualify if:
- Sensory or motor deficits sufficient to interfere with testing (e.g., blindness, severe cerebral palsy)
- Serious neurological disorders (e.g., epilepsy, stroke)
- Down syndrome, fragile X syndrome, Tourette syndrome, or fetal alcohol syndrome
- Bipolar disorder or a family history of bipolar disorder in a first-degree relative
- Other serious psychopathology that resulted in psychiatric hospitalization (e.g., for psychotic episode). The investigators will screen for this using the Diagnostic Interview for Children and Adolescents (DICA)-IV, and getting a complete developmental/medical history
- Serious physical handicaps that would interfere with performance on laboratory tasks
- IQ less than 50 and greater than 130
- Verbal mental age (VMA) less than 36 months (to exclude participants unable to understand simple task instructions)
- History of intolerance to MPH
- Weight less than 20 kg or greater than 59 kg (less than 44 pounds or greater than 130 pounds)
- Concomitant use of dextroamphetamine preparations (Dexedrine, Dextrostat), mixed amphetamine salts (Adderall XR), other MPH preparations (e.g., Concerta, Metadate); venlafaxine, bupropion, atomoxetine, guanfacine, modafinil.
- Concomitant use of any herbal preparations
- Medical condition for which stimulants are contraindicated (e.g., high blood pressure)
- Past treatment failure on a methylphenidate trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Related Publications (1)
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.
PMID: 37811711DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Deborah A. Pearson, Ph.D.
- Organization
- University of Texas Medical School at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah A. Pearson, PhD
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
September 1, 2005
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 9, 2013
Results First Posted
May 7, 2013
Record last verified: 2013-05