Phase 4 N=31 Randomized Quadruple-blind Treatment

Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory

Attention Deficit Hyperactivity Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00530257 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2011

Primary outcome: Primary: Test of Everyday Attention for Children: Walk, Don't Walk — 13.5; 11 units on a scale — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Placebo (Drug); OROS-methylphenidate (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Test of Everyday Attention for Children: Walk, Don't Walk	13.5; 11	<0.01 sig
PRIMARY Gordon Diagnostic System Continuous Performance Test	2; 4.5; 3; 10.5	<0.01 sig
PRIMARY Wechsler Intelligence Scale for Children-IV, Digit Span Subtest	5.5; 5.0	<0.05 sig
PRIMARY Test of Everyday Attention for Children-Sky Search Dual Task	3.8; 3.9	<0.01 sig
PRIMARY Test of Everyday Attention for Children: Score Dual Task (DT)	14; 13	<0.01 sig
PRIMARY Test of Everyday Attention for Children: Creature Counting	4.9; 4.8	<0.01 sig
PRIMARY Test of Everyday Attention for Children: Map Mission	27.5; 27	<0.01 sig
PRIMARY Test of Everyday Attention for Children: Sky Search	5.8; 4.5	<0.01 sig
PRIMARY Test of Everyday Attention for Children: Opposite Worlds	38.5; 47.5	<0.01 sig
SECONDARY Behavior Rating Inventory of Executive Function	—	—
SECONDARY ADHD Rating Scale-IV, Parent and Teacher Version	70.6; 92.6; 64.8; 89.6; 61.1; 73.3	<0.05 sig

Summary

This study investigates whether OROS-methylphenidate improves performance on different aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder (ADHD).

Eligibility Criteria

Inclusion Criteria

Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined Type
Parent and Teacher Ratings >85 percentile on inattention and/or hyperactivity/impulsivity scales
Estimated Intelligence Quotient (IQ) > 80 on Wechsler Abbreviated Scale of Intelligence or similar IQ test

Exclusion Criteria

Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization, psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing of the gastrointestinal tract, or epilepsy
Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to warrant separate treatment, suicidal or homicidal behavior or ideation
Use within 14-days of a monoamine oxidase inhibitor
History of side effects on any methylphenidate preparation that required stopping the medication
Inability to swallow a capsule or tablet
Chronic treatment with coumarin, clonidine, or tricyclic antidepressants

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00530257). 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.