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A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder

NCT00181571 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2013-06-27

No results posted yet for this study

Summary

This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.

Conditions

  • ADHD

Interventions

DRUG

methylphenidate HCl (Concerta)

up to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight.

DRUG

Placebo

up to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight.

Sponsors & Collaborators

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Joseph Biederman, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00181571 on ClinicalTrials.gov