CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
Methylphenidate-extended release +2 moredrug
Likely dose
Methylphenidate extended-release 10-20 mg (lower weight group 20-24 kg) or 20 mg (medium weight group); immediate-release 2.5-5 mg (lower weight group); dosing adjusted by body weight, 1 week per dose levelAI-extracted
Key inclusion· 4
  • ✓Confirmed diagnosis of autistic disorder per ADI-R and ADOS
  • ✓For ADHD/Autism group: current ADHD symptoms
  • ✓Verbal mental age ≥36 months to understand task instructions
  • ✓IQ between 50 and 130
Key exclusion· 10
  • ✕History of intolerance to methylphenidate
  • ✕Weight outside 20-59 kg (44-130 lbs)
  • ✕Concurrent use of other stimulants (amphetamines, other methylphenidate formulations)
  • ✕Concurrent use of venlafaxine, bupropion, atomoxetine, guanfacine, or modafinil

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00178503
NCT00178503Phase 3Completed
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ADHD Symptoms in Autism: Cognition, Behavior, Treatment

The University of Texas Health Science Center, Houston·interventional·Posted Sep 15, 2005·Updated May 9, 2013

In Brief

A Phase 3 clinical trial evaluating Methylphenidate-extended release, Methylphenidate-immediate release, and 1 other intervention for Autism and Attention Deficit Disorder With Hyperactivity. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism, Attention Deficit Disorder With Hyperactivity
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartSep 1, 2005
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.8 years ago

Interventions

Methylphenidate-extended releasedrug

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 releasedrug

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.

Placeboother

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.