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Clinical Trials/NCT00048360
NCT00048360
Completed
Phase 3

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

GlaxoSmithKline1 site in 1 country162 target enrollmentOctober 2002
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ConditionsAttention Deficit Disorder
DrugsExtended-release bupropion hydrochloride

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Attention Deficit Disorder
Sponsor
GlaxoSmithKline
Enrollment
162
Locations
1
Primary Endpoint
ADHD Rating Scale
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
June 2003
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

ADHD Rating Scale

Secondary Outcomes

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

Study Sites (1)

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