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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
OROS methylphenidate
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, side effects, sleep, dopamine, pharmacogenetics

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental retardation psychoses seizure disorder

Sites / Locations

  • HALP Clinic, University of Illinois at CHicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

ADHD RS

Secondary Outcome Measures

CGI-S
VItal Signs
Sleep Questionnaire
Side Effects rating Scale

Full Information

First Posted
April 18, 2008
Last Updated
April 21, 2008
Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00663442
Brief Title
Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Dose Response Pharmacogenetic Study of ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, side effects, sleep, dopamine, pharmacogenetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
OROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)
Intervention Type
Drug
Intervention Name(s)
OROS methylphenidate
Other Intervention Name(s)
Concerta
Intervention Description
18, 36, 54 mg
Primary Outcome Measure Information:
Title
ADHD RS
Time Frame
weekly
Secondary Outcome Measure Information:
Title
CGI-S
Time Frame
weekly
Title
VItal Signs
Time Frame
weekly
Title
Sleep Questionnaire
Time Frame
weekly
Title
Side Effects rating Scale
Time Frame
weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6-17 DSM IV criteria for ADHD Parents willing to complete measures Exclusion Criteria: Mental retardation psychoses seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Stein, Ph.D.
Organizational Affiliation
Univesity of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
HALP Clinic, University of Illinois at CHicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14595084
Citation
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.
Results Reference
result
PubMed Identifier
15827573
Citation
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.
Results Reference
result

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

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