Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD) - Full Text View

Sponsors and Collaborators:	University of Illinois National Institute of Mental Health (NIMH)
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00663442

Purpose

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

Condition	Intervention	Phase
ADHD	Drug: OROS methylphenidate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Dose Response Pharmacogenetic Study of ADHD

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Dopamine Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:

ADHD RS [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CGI-S [ Time Frame: weekly ] [ Designated as safety issue: No ]
VItal Signs [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Sleep Questionnaire [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Side Effects rating Scale [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Enrollment:	48
Study Start Date:	December 1999
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)	Drug: OROS methylphenidate 18, 36, 54 mg

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Mental retardation psychoses seizure disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663442

Locations

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

Sponsors and Collaborators

University of Illinois

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Mark A Stein, Ph.D.

Univesity of Illinois at Chicago

More Information

Publications:

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.

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.

Responsible Party:	( Mark A. Stein Ph.D. )
Study ID Numbers:	K24-MHO1823
Study First Received:	April 18, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00663442 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Illinois:

ADHD
side effects
sleep
dopamine
pharmacogenetics

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Methylphenidate
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Central Nervous System Stimulants
Dopamine Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants

Pharmacologic Actions
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009