EpilepsyPhase 3NCT00064467
Lethargic Depression Study
A Phase 3 study testing Extended-release bupropion (HCl) in people with Epilepsy and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 24 sites in United States.
Trial summary
This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Major Depressive Disorder (MDD)
- What is being tested?
- Extended-release bupropion (HCl)
- How many people
- 268 participants
- Where
- 24 sitesUnited States
- Study dates
- Jun 2003to May 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years.
- Generally in good health.
- Subject must read and write at a level sufficient to provide written informed consent.
Who cannot join
- Current or past history of seizure disorder.
- Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder.
- Currently using illicit drugs or other psychotropic drugs.
- Patient poses a current suicidal risk or has attempted suicide in the past 6 months.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Austin, Texas, 78746
GSK Investigational Site
Beachwood, Ohio, 44122
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Cedar Rapids, Iowa, 52401
GSK Investigational Site
Cromwell, Connecticut, 06416
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Denver, Colorado, 80212
GSK Investigational Site
Farmington Hills, Michigan, 48336
GSK Investigational Site
Hamden, Connecticut, 06518
GSK Investigational Site
Houston, Texas, 77004
GSK Investigational Site
Lake Jackson, Texas, 77566
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Middletown, Connecticut, 06457
GSK Investigational Site
Moorestown, New Jersey, 08057
GSK Investigational Site
Oak Brook, Illinois, 60523
GSK Investigational Site
Portland, Oregon, 97201
GSK Investigational Site
Ridgeland, Mississippi, 39157
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Sherman Oaks, California, 91403
GSK Investigational Site
Temecula, California, 92591
About this study
Official title: An 8 Week, Multicenter, Randomized, Double-blind, Placebo Controlled Comparison of the Efficacy of Extended Release Bupropion Hydrochloride and Placebo in the Treatment of Adult Outpatients With Major Depressive Disorder With Lethargic Symptoms
This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.
Read the detailed description
A Multicenter, Double-Blind, Placebo-controlled comparison of the efficacy and safety of flexible dose extended-release bupropion (HCl) 300-450 mg/day and placebo administered for eight weeks for the treatment of adult outpatients with major depressive disorder including symptoms of decreased energy, pleasure, and interest
- Conditions
- Epilepsy, Major Depressive Disorder (MDD)
- Being tested
- Extended-release bupropion (HCl)
- Keywords
- lethargic, decreased interest, decreased motivation, depression
- Medical subject headings
- Epilepsy, Depressive Disorder, Major, Stupor, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release bupropion (HCl)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Secondary outcomes (1)
Percent of responders. Percent of remitters. 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 posted10 Jul 2003 (estimated)
- Study startJun 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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
- 268 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064467
- Sponsor's protocol ID
- AK130931
- Status last verified
- May 2017
- First submitted
- 8 Jul 2003
- Last updated
- 30 May 2017
- Results posted
- No
Publications
Rush J, VanMeter SA, Wightman D, Hampton KD, Krishen A, Modell JG. Wellbutrin XL for the treatment of adults with major depressive disorder. American Psychiatric Association 158th Annual Meeting, Atlanta, GA, 21-26 May, 2005, Abstract No. 787.
Jefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602.
PubMed 16848645Rush J, VanMeter SA, Wightman DS, Hampton KD, Krishen A, Modell JG. Bupropion XL for the treatment of adults with major depressive disorder. 45th Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting, Boca Raton, FL, 6-9June, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Week, Multicenter, Randomized, Double-blind, Placebo Controlled Comparison of the Efficacy of Extended Release Bupropion Hydrochloride and Placebo in the Treatment of Adult Outpatients With Major Depressive Disorder With Lethargic Symptoms
- ClinicalTrials.gov ID
- NCT00064467
- Acronym / sponsor ID
- AK130931
- Conditions
- Epilepsy, Major Depressive Disorder (MDD)
- Keywords
- lethargic, decreased interest, decreased motivation, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 10 Jul 2003 (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 study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.
Detailed description
A Multicenter, Double-Blind, Placebo-controlled comparison of the efficacy and safety of flexible dose extended-release bupropion (HCl) 300-450 mg/day and placebo administered for eight weeks for the treatment of adult outpatients with major depressive disorder including symptoms of decreased energy, pleasure, and interest
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years.
- Generally in good health.
- Subject must read and write at a level sufficient to provide written informed consent.
Key exclusion criteria (4 listed)
- Current or past history of seizure disorder.
- Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder.
- Currently using illicit drugs or other psychotropic drugs.
- Patient poses a current suicidal risk or has attempted suicide in the past 6 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 (HCl) | Drug | – |
Primary outcome
Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
1 secondary outcome
Percent of responders. Percent of remitters. 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 30 May 2017.
- Results publicationRush J, VanMeter SA, Wightman D, Hampton KD, Krishen A, Modell JG. Wellbutrin XL for the treatment of adults with major depressive disorder. American Psychiatric Association 158th Annual Meeting, Atlanta, GA, 21-26 May, 2005, Abstract No. 787.
- Results publication: PubMed 16848645Jefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602.
- Results publicationRush J, VanMeter SA, Wightman DS, Hampton KD, Krishen A, Modell JG. Bupropion XL for the treatment of adults with major depressive disorder. 45th Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting, Boca Raton, FL, 6-9June, 2005.
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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 Trials, MD study director
GlaxoSmithKline
24 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 (HCl) in people with Epilepsy and Major Depressive Disorder (MDD), run by GlaxoSmithKline at 24 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 3 inclusion and 4 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00064467, which also lists 3 linked publications.
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 30 May 2017.