Attention Deficit DisorderPhase 3NCT00048360
Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
A Phase 3 study testing Extended-release bupropion hydrochloride in people with Attention Deficit Disorder, run by GlaxoSmithKline at 21 sites in United States.
Trial summary
This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Disorder
- What is being tested?
- Extended-release bupropion hydrochloride
- How many people
- 162 participants
- Where
- 21 sitesUnited States
- Study dates
- Oct 2002to Jun 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient must be diagnosed with ADHD.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
GSK Clinical Trials Call Center
Beachwood, Ohio, 44122
GSK Clinical Trials Call Center
Bellaire, Texas, 77401
GSK Clinical Trials Call Center
Burlington, Vermont, 05405
GSK Clinical Trials Call Center
Cambridge, Massachusetts, 02138
GSK Clinical Trials Call Center
Chapel Hill, North Carolina, 27514
GSK Clinical Trials Call Center
Chula Vista, California, 91910
GSK Clinical Trials Call Center
Cincinnati, Ohio, 45267-0559
GSK Clinical Trials Call Center
Houston, Texas, 77007
GSK Clinical Trials Call Center
Lafayette, California, 94549
GSK Clinical Trials Call Center
Northridge, California, 91324
GSK Clinical Trials Call Center
Omaha, Nebraska, 68105
GSK Clinical Trials Call Center
Paducah, Kentucky, 42003
GSK Clinical Trials Call Center
Phoenix, Arizona, 85016
GSK Clinical Trials Call Center
Portland, Oregon, 97209
GSK Clinical Trials Call Center
Rockville, Maryland, 20852
GSK Clinical Trials Call Center
Salt Lake City, Utah, 84132
GSK Clinical Trials Call Center
Seattle, Washington, 98104
GSK Clinical Trials Call Center
Spring Valley, California, 91978
GSK Clinical Trials Call Center
West Palm Beach, Florida, 33407
GSK Clinical Trials Call Center
Woodstock, Vermont, 05091
GSK Clinical Trials Call Center
Worcester, Massachusetts, 01655
About this study
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
This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).
- Conditions
- Attention Deficit Disorder
- Being tested
- Extended-release bupropion hydrochloride
- Keywords
- ADD, ADHD, attention deficit, hyperactivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release bupropion hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale
Secondary outcomes (2)
Clinical Global Impressions -Severity and Improvement.
Quality of Life Enjoyment and Satisfaction Questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2002 (estimated)
- Study startOct 2002
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 162 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trial, MD, Study chair, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048360
- Sponsor's protocol ID
- AK130934
- Status last verified
- Feb 2013
- First submitted
- 30 Oct 2002
- Last updated
- 12 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00048360
- Acronym / sponsor ID
- AK130934
- Conditions
- Attention Deficit Disorder
- Keywords
- ADD, ADHD, attention deficit, hyperactivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 31 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a placebo controlled study evaluating the efficacy and safety of medication in adults with Attention-Deficit Hyperactivity Disorder (ADHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient must be diagnosed with ADHD.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-release bupropion hydrochloride | Drug | – |
Primary outcome
ADHD Rating Scale
2 secondary outcomes
Clinical Global Impressions -Severity and Improvement.
Quality of Life Enjoyment and Satisfaction Questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trial, MD study chair
GlaxoSmithKline
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended-release bupropion hydrochloride in people with Attention Deficit Disorder, run by GlaxoSmithKline at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.