Clinical trial NCT00530257: Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory
Official title: Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Methylphenidate
Attention
Working Memory
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2007-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: This study investigates the effect of Osmotic-Release Oral System (OROS)-methylphenidate, a long-acting stimulant, on multiple dimensions of attention and on working memory. Specifically, we will investigate the following two hypotheses: (1) OROS-methylphenidate will result in improved performance on measures assessing multiple domains of attention, including sustained attention, attentional control, selective attention, and divided attention, and (2) OROS-methylphenidate will result in improved performance on measures of working memory. In addition we will use the study to collect pilot data on whether the magnitude of the effect of OROS-methylphenidate varies across the different components of attention and working memory and whether improvement across any of these measures is helpful in predicting parent or teacher ratings of improvement.

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

Primary outcomes:
measure: Test of Everyday Attention for Children: Walk, Don't Walk
timeFrame: 2 weeks
measure: Gordon Diagnostic System Continuous Performance Test
timeFrame: 2 weeks
measure: Wechsler Intelligence Scale for Children-IV, Digit Span Subtest
timeFrame: 2 weeks
measure: Test of Everyday Attention for Children-Sky Search Dual Task
timeFrame: 2 weeks
measure: Test of Everyday Attention for Children: Score Dual Task (DT)
timeFrame: 2 weeks
measure: Test of Everyday Attention for Children: Creature Counting
timeFrame: 2 weeks
measure: Test of Everyday Attention for Children: Map Mission
timeFrame: 2 weeks
measure: Test of Everyday Attention for Children: Sky Search
timeFrame: 2 weeks
measure: Test of Everyday Attention for Children: Opposite Worlds
timeFrame: 2 weeks
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function
timeFrame: 2 Weeks
measure: ADHD Rating Scale-IV, Parent and Teacher Version
timeFrame: 2 Weeks
Other outcomes:
measure: Stimulant Side Effect Rating Scale
timeFrame: 2 weeks
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Nathan J Blum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: