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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00048360
Other study ID # AK130934
Secondary ID
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


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.
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