Back to resultsAttention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
Primary Purpose
Attention Deficit Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Extended-release bupropion hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder focused on measuring ADD, ADHD, attention deficit, hyperactivity
Eligibility 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.
Sites / Locations
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
Outcomes
Primary Outcome Measures
ADHD Rating Scale
Secondary Outcome Measures
Clinical Global Impressions -Severity and Improvement.
Quality of Life Enjoyment and Satisfaction Questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048360
Brief Title
Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder
Keywords
ADD, ADHD, attention deficit, hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
162 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Extended-release bupropion hydrochloride
Primary Outcome Measure Information:
Title
ADHD Rating Scale
Secondary Outcome Measure Information:
Title
Clinical Global Impressions -Severity and Improvement.
Title
Quality of Life Enjoyment and Satisfaction Questionnaire.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trial, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Chair
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
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Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
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