Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults

February 11, 2013 updated by: GlaxoSmithKline

An 8-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Comparison of Extended-Release Bupropion Hydrochloride 300-450 mg/Day to Assess the Efficacy, Safety, and Effects on Health Outcomes in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder

This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • GSK Clinical Trials Call Center
    • California
      • Chula Vista, California, United States, 91910
        • GSK Clinical Trials Call Center
      • Lafayette, California, United States, 94549
        • GSK Clinical Trials Call Center
      • Northridge, California, United States, 91324
        • GSK Clinical Trials Call Center
      • Spring Valley, California, United States, 91978
        • GSK Clinical Trials Call Center
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • GSK Clinical Trials Call Center
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • GSK Clinical Trials Call Center
    • Maryland
      • Rockville, Maryland, United States, 20852
        • GSK Clinical Trials Call Center
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • GSK Clinical Trials Call Center
      • Worcester, Massachusetts, United States, 01655
        • GSK Clinical Trials Call Center
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • GSK Clinical Trials Call Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • GSK Clinical Trials Call Center
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • GSK Clinical Trials Call Center
      • Cincinnati, Ohio, United States, 45267-0559
        • GSK Clinical Trials Call Center
    • Oregon
      • Portland, Oregon, United States, 97209
        • GSK Clinical Trials Call Center
    • Texas
      • Bellaire, Texas, United States, 77401
        • GSK Clinical Trials Call Center
      • Houston, Texas, United States, 77007
        • GSK Clinical Trials Call Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • GSK Clinical Trials Call Center
    • Vermont
      • Burlington, Vermont, United States, 05405
        • GSK Clinical Trials Call Center
      • Woodstock, Vermont, United States, 05091
        • GSK Clinical Trials Call Center
    • Washington
      • Seattle, Washington, United States, 98104
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patient must be diagnosed with ADHD.

Exclusion Criteria:

  • Patient has a current or past history of seizure disorder, brain injury, anorexia nervosa or bulimia.
  • Patient has a current diagnosis of Major Depressive Disorder (MDD).
  • Patient has a current primary diagnosis of, or received treatment for, Panic Disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD) or Acute Stress Disorder within the previous 12 months.
  • Patient has a lifetime diagnosis of bipolar disorder, schizophrenia or other psychotic disorders.
  • Patient has a positive urine test at screening for presence of illicit drugs or alcohol abuse during the past 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ADHD Rating Scale

Secondary Outcome Measures

Outcome Measure
Clinical Global Impressions -Severity and Improvement.
Quality of Life Enjoyment and Satisfaction Questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Chair: GSK Clinical Trial, MD, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (ACTUAL)

June 1, 2003

Study Completion (ACTUAL)

June 1, 2003

Study Registration Dates

First Submitted

October 30, 2002

First Submitted That Met QC Criteria

October 30, 2002

First Posted (ESTIMATE)

October 31, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK130934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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