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OpenTrials
Completed

NCT Number: NCT00663442

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

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

Completed

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HALP Clinic, University of Illinois at CHicago

Chicago, Illinois, 60608, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Mental retardation psychoses seizure disorder

Treatment and study plan

OROS methylphenidate

Drug

18, 36, 54 mg

Other names: Concerta

Primary outcomes

  1. ADHD RS

    Time frame: weekly

Secondary outcomes

  1. CGI-S

    Time frame: weekly

  2. VItal Signs

    Time frame: weekly

  3. Sleep Questionnaire

    Time frame: weekly

  4. Side Effects rating Scale

    Time frame: weekly

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Dose Response Pharmacogenetic Study of ADHD

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Apr 22, 2008
Registry last updated
Apr 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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