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Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR

NCT00393042 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2017-04-19

Study results available
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Summary

The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications.

This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood.

It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Dexmethylphenidate

10, 20, 25-30 mg.

DRUG

Mixed Amphetamine Salts, ER

10, 20, 25-30

DRUG

placebo

randomized placebo week during each 4 week period

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Mark A Stein, PhD · University of Illinois-Chicago; Hyperactivity, Attention and Learning Problems Clinic (HALP)

  • Elizabeth Charney, MD · University of Illinois-Chicago, Hyperactivity, Attention, and Learning Problems Clinic (HALP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00393042 on ClinicalTrials.gov