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Phase 3 N=24 Randomized Quadruple-blind Treatment

Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children

Autism · Attention Deficit Disorder With Hyperactivity

Bottom Line

View on ClinicalTrials.gov: NCT00178503 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Mean Conners' Teacher ADHD Index T Score by Dose — 72.8; 63.1; 63.6; 61.5 Units on a scale (T-scores) — p==.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Methylphenidate-extended release (Drug); Methylphenidate-immediate release (Drug); Placebo (Other)
Age
Pediatric · 7+ yrs
Sex
All
Sponsor
The University of Texas Health Science Center, Houston
Primary completion
May 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Conners' Teacher ADHD Index T Score by Dose		 72.8; 63.1; 63.6; 61.5 =.001 sig
PRIMARY
Mean Continuous Performance Test (CPT)-Commission Errors by Dose		 2.75; 1.11; 1.18; 1.24 .005 sig
SECONDARY
Mean Conners' Parent ADHD Index T Score by Week		 70.1; 64.9; 62.3; 59.9 <.001 sig

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00178503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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