Status:
COMPLETED
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Autism
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
7-12 years
Phase:
PHASE2
PHASE3
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 effectivene...
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 emotiona...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00178503
Start Date
September 1 2005
End Date
May 1 2011
Last Update
May 9 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77054