Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)
Dose Response Pharmacogenetic Study of ADHD
1 other identifier
interventional
48
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 1999
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedApril 22, 2008
April 1, 2008
4.9 years
April 18, 2008
April 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ADHD RS
weekly
Secondary Outcomes (4)
CGI-S
weekly
VItal Signs
weekly
Sleep Questionnaire
weekly
Side Effects rating Scale
weekly
Study Arms (1)
1
EXPERIMENTALOROS methylphenidate 18, 36, 54m placebo in randomized order (except never starting with highest dose)
Interventions
Eligibility Criteria
You may qualify if:
- DSM IV criteria for ADHD Parents willing to complete measures
You may not qualify if:
- Mental retardation psychoses seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HALP Clinic, University of Illinois at CHicago
Chicago, Illinois, 60608, United States
Related Publications (2)
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.
PMID: 14595084RESULTStein 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.
PMID: 15827573RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Stein, Ph.D.
Univesity of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 18, 2008
First Posted
April 22, 2008
Study Start
December 1, 1999
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
April 22, 2008
Record last verified: 2008-04