Phase 3
Completed N=24
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
Autism Spectrum Disorder · Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00178503 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: 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
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.
Outcome Measures
| Outcome | Result | p-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 |
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
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. Informational only — not medical advice.