Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)

University of Illinois

Status and phase: Completed; Phase 4

Conditions: ADHD

Treatments: Drug: OROS methylphenidate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00663442

K24-MHO1823

Details and patient eligibility

About

Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted.

Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response

Enrollment: 48 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6-17 DSM IV criteria for ADHD Parents willing to complete measures

Exclusion criteria

• Mental retardation psychoses seizure disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 1 patient group

1

Experimental group

Description:

OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)

Treatment:

Drug: OROS methylphenidate