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Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)

NCT00889915 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2013-09-30

Study results available
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Summary

This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Methylphenidate transdermal system

Not specified in protocol; determined by local standard of care.

DRUG

Lisdexamfetamine dimesylate

Not specified in protocol; determined by local standard of care.

DRUG

Osmotic-release oral system methylphenidate (OROS MPH)

Not specified in protocol; determined by local standard of care.

DRUG

Mixed amphetamine salts extended release

Not specified in protocol; determined by local standard of care.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • John S. March, MD, MPH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

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 NCT00889915 on ClinicalTrials.gov