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

ADHD Clinical Trial

Official title:

Dose Response Pharmacogenetic Study of ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663442
• Other study ID #: K24-MHO1823
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2008
• Last updated: April 21, 2008
• Start date: December 1999
• Est. completion date: November 2004

Study information

• Verified date: April 2008
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Mental retardation psychoses seizure disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• OROS methylphenidate
18, 36, 54 mg

Locations

Country	Name	City	State
United States	HALP Clinic, University of Illinois at CHicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD RS		weekly	No
Secondary	CGI-S		weekly	No
Secondary	VItal Signs		weekly	Yes
Secondary	Sleep Questionnaire		weekly	Yes
Secondary	Side Effects rating Scale		weekly	Yes