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

Phase 4

Completed

• Conditions: ADHD
• Interventions: Drug: OROS methylphenidate

• Registration Number: NCT00663442
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Status Verified: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-21
• Last Update Submitted: 2008-04-21
• Study First Posted: 2008-04-22
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

• Mental retardation psychoses seizure disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
ADHD RS	weekly

Secondary Outcome Measures

Name	Time	Method
CGI-S	weekly
VItal Signs	weekly
Sleep Questionnaire	weekly
Side Effects rating Scale	weekly

Trial Locations

Locations (1)

HALP Clinic, University of Illinois at CHicago; 🇺🇸 Chicago, Illinois, United States