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

Tracking Information

First Received Date ^ICMJE

October 30, 2002

Last Updated Date

February 24, 2006

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

ADHD Rating Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00048360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Attention Deficit Disorder

Intervention ^ICMJE

Drug: Extended-release bupropion hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

162

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00048360

Responsible Party

Study ID Numbers ^ICMJE

AK130934

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

GSK Clinical Trial, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP