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

NCT ID: NCT00663442

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2004-11-30

Brief Summary

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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

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Conditions

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ADHD

Keywords

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ADHD side effects sleep dopamine pharmacogenetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

OROS methylphenidate

Intervention Type DRUG

18, 36, 54 mg

Interventions

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OROS methylphenidate

18, 36, 54 mg

Intervention Type DRUG

Other Intervention Names

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Concerta

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Mental retardation psychoses seizure disorder
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Principal Investigators

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Mark A Stein, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Univesity of Illinois at Chicago

Locations

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HALP Clinic, University of Illinois at CHicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Stein MA, Sarampote CS, Waldman ID, Robb AS, Conlon C, Pearl PL, Black DO, Seymour KE, Newcorn JH. A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2003 Nov;112(5):e404. doi: 10.1542/peds.112.5.e404.

Reference Type RESULT
PMID: 14595084 (View on PubMed)

Stein MA, Waldman ID, Sarampote CS, Seymour KE, Robb AS, Conlon C, Kim SJ, Cook EH. Dopamine transporter genotype and methylphenidate dose response in children with ADHD. Neuropsychopharmacology. 2005 Jul;30(7):1374-82. doi: 10.1038/sj.npp.1300718.

Reference Type RESULT
PMID: 15827573 (View on PubMed)

Other Identifiers

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K24-MHO1823

Identifier Type: -

Identifier Source: org_study_id