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

April 21, 2008 updated by: University of Illinois at Chicago

Dose Response Pharmacogenetic Study of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • HALP Clinic, University of Illinois at CHicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental retardation psychoses seizure disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)
Drug: OROS methylphenidate
18, 36, 54 mg
Other Names:
  • Concerta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADHD RS
Time Frame: weekly
weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
CGI-S
Time Frame: weekly
weekly
VItal Signs
Time Frame: weekly
weekly
Sleep Questionnaire
Time Frame: weekly
weekly
Side Effects rating Scale
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Mark A Stein, Ph.D., Univesity of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Primary Completion (ACTUAL)

November 1, 2004

Study Completion (ACTUAL)

November 1, 2004

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (ESTIMATE)

April 22, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K24-MHO1823

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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