Seasonal Affective DisorderPhase 3NCT00046241
Prevention of Seasonal Affective Disorder
A Phase 3 study testing Extended-release bupropion hydrochloride in people with Seasonal Affective Disorder, run by GlaxoSmithKline at 51 sites in 2 countries.
Trial summary
This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- Extended-release bupropion hydrochloride
- How many people
- 300 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.
Who cannot join
- Patient has a current or past history of seizure disorder or brain injury.
- Patient has a history or current diagnosis of anorexia nervosa or bulimia.
- Patient has recurrent summer depression more frequently than winter depression.
- Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- Patient has initiated psychotherapy within the last 3 months.
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States43 sites
GSK Clinical Trials Call Center
Albany, New York, 12208
GSK Clinical Trials Call Center
Anchorage, Alaska, 99508
GSK Clinical Trials Call Center
Baltimore, Maryland, 21204
GSK Clinical Trials Call Center
Beachwood, Ohio, 44122
GSK Clinical Trials Call Center
Bellevue, Washington, 98004
GSK Clinical Trials Call Center
Belmont, Massachusetts, 02478
GSK Clinical Trials Call Center
Boise, Idaho, 83702
GSK Clinical Trials Call Center
Brown Deer, Wisconsin, 53223
GSK Clinical Trials Call Center
Cedar Rapids, Iowa, 52401
GSK Clinical Trials Call Center
Chicago, Illinois, 60637
GSK Clinical Trials Call Center
Cincinnati, Ohio, 45267
GSK Clinical Trials Call Center
Clementon, New Jersey, 08021
GSK Clinical Trials Call Center
Dayton, Ohio, 45415
GSK Clinical Trials Call Center
Detroit, Michigan, 48207
GSK Clinical Trials Call Center
East Providence, Rhode Island, 02915
GSK Clinical Trials Call Center
Edwardsville, Illinois, 62025
GSK Clinical Trials Call Center
Eugene, Oregon, 97401
GSK Clinical Trials Call Center
Falls Church, Virginia, 22041
GSK Clinical Trials Call Center
Farmington Hills, Michigan, 48334
GSK Clinical Trials Call Center
Hamden, Connecticut, 06518
GSK Clinical Trials Call Center
Havertown, Pennsylvania, 19083
GSK Clinical Trials Call Center
Jenkintown, Pennsylvania, 19046
GSK Clinical Trials Call Center
Kenilworth, New Jersey, 07033
GSK Clinical Trials Call Center
Lafayette, Indiana, 47905
GSK Clinical Trials Call Center
Marion, Ohio, 43302
GSK Clinical Trials Call Center
Minneapolis, Minnesota, 55454
GSK Clinical Trials Call Center
New York, New York, 10021
GSK Clinical Trials Call Center
New York, New York, 10024
GSK Clinical Trials Call Center
New York, New York, 10025
GSK Clinical Trials Call Center
Oak Brook, Illinois, 60523
GSK Clinical Trials Call Center
Oakbrook Terrace, Illinois, 60181
GSK Clinical Trials Call Center
Omaha, Nebraska, 68198
GSK Clinical Trials Call Center
Overland Park, Kansas, 66211
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, 19131
GSK Clinical Trials Call Center
Portland, Oregon, 97210
GSK Clinical Trials Call Center
Portland, Oregon, 97239
GSK Clinical Trials Call Center
Princeton, New Jersey, 08540
GSK Clinical Trials Call Center
Rochester, New York, 14618
GSK Clinical Trials Call Center
Rockville, Maryland, 20852
GSK Clinical Trials Call Center
Seattle, Washington, 98105
GSK Clinical Trials Call Center
Spokane, Washington, 99204
GSK Clinical Trials Call Center
St Louis, Missouri, 63108
GSK Clinical Trials Call Center
Woodstock, Vermont, 05091
Canada8 sites
GSK Clinical Trials Call Center
Calgary, Alberta, T2X 2A8
GSK Clinical Trials Call Center
Edmonton, Alberta, T6L 5X8
GSK Clinical Trials Call Center
Kelowna, British Columbia, V1Y 2A3
GSK Clinical Trials Call Center
Montreal, Quebec, H2L 1H9
GSK Clinical Trials Call Center
Sherbrooke, Quebec, J1G 1W4
GSK Clinical Trials Call Center
Toronto, Ontario, M4T 1K2
GSK Clinical Trials Call Center
Toronto, Ontario, M9W 4L6
GSK Clinical Trials Call Center
Winnipeg, Manitoba, R3E 3N4
About this study
Official title: A 7 Month, Multicenter, Randomized, Double-blind, Placebo-controlled Comparison of 150-300mg/Day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).
- Conditions
- Seasonal Affective Disorder
- Being tested
- Extended-release bupropion hydrochloride
- Keywords
- seasonal depression winter blues winter depression
- Medical subject headings
- Seasonal Affective Disorder
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.
Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
Secondary outcomes (1)
Change in HAMD-24 and -17 total score. Change in pain score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2002 (estimated)
- Study startSep 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 Seasonal Affective 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trial, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046241
- Sponsor's protocol ID
- AK130930
- Status last verified
- Jan 2017
- First submitted
- 24 Sep 2002
- Last updated
- 23 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 7 Month, Multicenter, Randomized, Double-blind, Placebo-controlled Comparison of 150-300mg/Day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
- ClinicalTrials.gov ID
- NCT00046241
- Acronym / sponsor ID
- AK130930
- Conditions
- Seasonal Affective Disorder
- Keywords
- seasonal depression winter blues winter depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2002 (actual)
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 25 Sep 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 effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).
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 (1 listed)
- Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.
Key exclusion criteria (5 listed)
- Patient has a current or past history of seizure disorder or brain injury.
- Patient has a history or current diagnosis of anorexia nervosa or bulimia.
- Patient has recurrent summer depression more frequently than winter depression.
- Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- Patient has initiated psychotherapy within the last 3 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
Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
1 secondary outcome
Change in HAMD-24 and -17 total score. Change in pain score.
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 23 Jan 2017.
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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 director
GlaxoSmithKline
51 sites in 2 countries: 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 Seasonal Affective Disorder, run by GlaxoSmithKline at 51 sites in 2 countries.
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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Canada. 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?
Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.. 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 23 Jan 2017.