Clinical trial NCT00048360: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder
Keywords: ADD
ADHD
attention deficit
hyperactivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-10-31
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: ADHD Rating Scale
Secondary outcomes:
measure: Clinical Global Impressions -Severity and Improvement.
measure: Quality of Life Enjoyment and Satisfaction Questionnaire.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Chula Vista
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Lafayette
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Northridge
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Spring Valley
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: West Palm Beach
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Paducah
country: United States
facility: GSK Clinical Trials Call Center
state: Kentucky
city: Rockville
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Cambridge
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Worcester
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Omaha
country: United States
facility: GSK Clinical Trials Call Center
state: Nebraska
city: Chapel Hill
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Beachwood
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Cincinnati
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Portland
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Bellaire
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Houston
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Salt Lake City
country: United States
facility: GSK Clinical Trials Call Center
state: Utah
city: Burlington
country: United States
facility: GSK Clinical Trials Call Center
state: Vermont
city: Woodstock
country: United States
facility: GSK Clinical Trials Call Center
state: Vermont
city: Seattle
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trial, MD
role: STUDY_CHAIR
References: