Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00048360

Purpose

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

Condition	Intervention	Phase
Attention Deficit Disorder	Drug: Extended-release bupropion hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

ADHD Rating Scale

Secondary Outcome Measures:

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

Estimated Enrollment:	162
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048360

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Chair:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00048360 History of Changes
Other Study ID Numbers:	AK130934
Study First Received:	October 30, 2002
Last Updated:	February 24, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

ADD
ADHD
attention deficit
hyperactivity

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupropion
Antidepressive Agents, Second-Generation

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012