Study of the Effects of OROS Methylphenidate (Concerta) on Attention and Memory

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: OROS Methylphenidate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Children's Hospital of Philadelphia

Official(s) and/or principal investigator(s):
Nathan J Blum, M.D., Principal Investigator, Affiliation: Children's Hospital of Philadelphia

Overall contact:
Nathan Blum, M.D., Phone: 215-590-7466, Email: blum@email.chop.edu

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

Official title: Effect of OROS-Methylphenidate (Concerta) on Different Domains of Attention and Working Memory in Children With Attention-Deficit/Hyperactivity Disorder

Study design: Treatment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment

Primary outcome:

Test of Everyday Attention for Children

Gordon Diagnostic System Continuous Performance Test

Wechsler Intelligence Scale for Children-IV, Digit Span subtest

Secondary outcome:

Behavior Rating Inventory of Executive Function

ADHD Rating Scale-IV, Parent and Teacher Version

Detailed description: This study investigates the effect of 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.

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Meets DSM-IV Criteria for ADHD. Combined Type

- Parent and Teacher Ratings >85 percentile on inattention and/or

hyperactivity/impulsivity scales

- Estimated 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, 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

Nathan Blum, M.D., Phone: 215-590-7466, Email: blum@email.chop.edu

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Nathan J Blum, MD, Phone: 215-590-7466, Email: blum@email.chop.edu
Thomas Power, Ph.D., Sub-Investigator
Marianne Glanzman, M.D., Sub-Investigator

Starting date: June 2004
Ending date: August 2008
Last updated: March 26, 2008