Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00048360
First received: October 30, 2002
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder |
Drug: Extended-release bupropion hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- ADHD Rating Scale
Secondary Outcome Measures:
- Clinical Global Impressions -Severity and Improvement.
- Quality of Life Enjoyment and Satisfaction Questionnaire.
| Estimated Enrollment: | 162 |
| Study Start Date: | October 2002 |
| Study Completion Date: | June 2003 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048360
Locations
| United States, Arizona | |
| GSK Clinical Trials Call Center | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| GSK Clinical Trials Call Center | |
| Chula Vista, California, United States, 91910 | |
| GSK Clinical Trials Call Center | |
| Lafayette, California, United States, 94549 | |
| GSK Clinical Trials Call Center | |
| Northridge, California, United States, 91324 | |
| GSK Clinical Trials Call Center | |
| Spring Valley, California, United States, 91978 | |
| United States, Florida | |
| GSK Clinical Trials Call Center | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Kentucky | |
| GSK Clinical Trials Call Center | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Maryland | |
| GSK Clinical Trials Call Center | |
| Rockville, Maryland, United States, 20852 | |
| United States, Massachusetts | |
| GSK Clinical Trials Call Center | |
| Cambridge, Massachusetts, United States, 02138 | |
| GSK Clinical Trials Call Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Nebraska | |
| GSK Clinical Trials Call Center | |
| Omaha, Nebraska, United States, 68105 | |
| United States, North Carolina | |
| GSK Clinical Trials Call Center | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
| GSK Clinical Trials Call Center | |
| Beachwood, Ohio, United States, 44122 | |
| GSK Clinical Trials Call Center | |
| Cincinnati, Ohio, United States, 45267-0559 | |
| United States, Oregon | |
| GSK Clinical Trials Call Center | |
| Portland, Oregon, United States, 97209 | |
| United States, Texas | |
| GSK Clinical Trials Call Center | |
| Bellaire, Texas, United States, 77401 | |
| GSK Clinical Trials Call Center | |
| Houston, Texas, United States, 77007 | |
| United States, Utah | |
| GSK Clinical Trials Call Center | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Vermont | |
| GSK Clinical Trials Call Center | |
| Burlington, Vermont, United States, 05405 | |
| GSK Clinical Trials Call Center | |
| Woodstock, Vermont, United States, 05091 | |
| United States, Washington | |
| GSK Clinical Trials Call Center | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Chair: | GSK Clinical Trial, MD | GlaxoSmithKline |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00048360 History of Changes |
| Other Study ID Numbers: | AK130934 |
| Study First Received: | October 30, 2002 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
ADD ADHD attention deficit hyperactivity |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bupropion Antidepressive Agents, Second-Generation |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013