Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults

Attention Deficit Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048360
• Other study ID #: AK130934
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2002
• Last updated: February 11, 2013
• Start date: October 2002
• Est. completion date: June 2003

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Extended-release bupropion hydrochloride

Locations

Country	Name	City	State
United States	GSK Clinical Trials Call Center	Beachwood	Ohio
United States	GSK Clinical Trials Call Center	Bellaire	Texas
United States	GSK Clinical Trials Call Center	Burlington	Vermont
United States	GSK Clinical Trials Call Center	Cambridge	Massachusetts
United States	GSK Clinical Trials Call Center	Chapel Hill	North Carolina
United States	GSK Clinical Trials Call Center	Chula Vista	California
United States	GSK Clinical Trials Call Center	Cincinnati	Ohio
United States	GSK Clinical Trials Call Center	Houston	Texas
United States	GSK Clinical Trials Call Center	Lafayette	California
United States	GSK Clinical Trials Call Center	Northridge	California
United States	GSK Clinical Trials Call Center	Omaha	Nebraska
United States	GSK Clinical Trials Call Center	Paducah	Kentucky
United States	GSK Clinical Trials Call Center	Phoenix	Arizona
United States	GSK Clinical Trials Call Center	Portland	Oregon
United States	GSK Clinical Trials Call Center	Rockville	Maryland
United States	GSK Clinical Trials Call Center	Salt Lake City	Utah
United States	GSK Clinical Trials Call Center	Seattle	Washington
United States	GSK Clinical Trials Call Center	Spring Valley	California
United States	GSK Clinical Trials Call Center	West Palm Beach	Florida
United States	GSK Clinical Trials Call Center	Woodstock	Vermont
United States	GSK Clinical Trials Call Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Rating Scale
Secondary	Clinical Global Impressions -Severity and Improvement.
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire.