Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Autism, Attention Deficit Disorder With Hyperactivity

In brief

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.

Key facts

Study ID

NCT00178503

Run by

The University of Texas Health Science Center, Houston

People needed

24

Starts

2005-09-01

Expected to finish

2011-05-01

Last updated by the study team

2013-05-09

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: accepted.

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…

• In both groups, exclusion criteria will include:
• 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)
• In the autism/ADHD group, further exclusion criteria apply to the MPH trial:
• 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

Where it is running

• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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