Depressive DisorderPhase 1NCT00069459
Seasonal Affective Depression (SAD) Study
A Phase 1 study testing Extended-release Bupropion Hydrochloride in people with Depressive Disorder, run by GlaxoSmithKline at 48 sites in United States.
Trial summary
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Extended-release Bupropion Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 48 sitesUnited States
- Study dates
- 23 Sep 2003to 3 Jun 2004
- Phase
- Phase 1
- 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
- History of Major Depressive Disorder (MDD) with a seasonal pattern.
Who cannot join
- Current or past history of seizure disorder or brain injury.
- History or current diagnosis of anorexia nervosa or bulimia.
- Recurrent summer depression more frequently than winter depression.
- Primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Post-traumatic Stress Disorder(PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- Initiated psychotherapy within the last 3 months.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Allentown, Pennsylvania, 18104
GSK Investigational Site
Anchorage, Alaska, 99508
GSK Investigational Site
Baltimore, Maryland, 21204
GSK Investigational Site
Belmont, Massachusetts, 02478
GSK Investigational Site
Boise, Idaho, 83702
GSK Investigational Site
Brown Deer, Wisconsin, 53223
GSK Investigational Site
Cedar Rapids, Iowa, 52401
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Columbus, Ohio, 43210
GSK Investigational Site
Edwardsville, Illinois, 62025
GSK Investigational Site
Eugene, Oregon, 97401
GSK Investigational Site
Farmington Hills, Michigan, 48334
GSK Investigational Site
Hamden, Connecticut, 06518
GSK Investigational Site
Havertown, Pennsylvania, 19083
GSK Investigational Site
Hoffman Estates, Illinois, 60194
GSK Investigational Site
Kenilworth, New Jersey, 07033
GSK Investigational Site
Lawrence, New York, 11559
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208
GSK Investigational Site
Lyndhurst, Ohio, 44124
GSK Investigational Site
Madison, Wisconsin, 53719
GSK Investigational Site
Menomonee Falls, Wisconsin, 53051
GSK Investigational Site
Middleton, Wisconsin, 53562-2215
GSK Investigational Site
Minneapolis, Minnesota, 55454
GSK Investigational Site
Moorestown, New Jersey, 08057
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
New York, New York, 10032
GSK Investigational Site
New York, New York, 10128
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Northfield, Illinois, 60093
GSK Investigational Site
Oak Brook, Illinois, 60523
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181
GSK Investigational Site
Omaha, Nebraska, 68198
GSK Investigational Site
Overland Park, Kansas, 66211
GSK Investigational Site
Philadelphia, Pennsylvania, 19106
GSK Investigational Site
Piscataway, New Jersey, 08854
GSK Investigational Site
Portland, Oregon, 97201
GSK Investigational Site
Portland, Oregon, 97209
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Princeton, New Jersey, 08540
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
Rockville, Maryland, 20852
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
St Louis, Missouri, 63108
GSK Investigational Site
Toledo, Ohio, 43623
GSK Investigational Site
Washington D.C., District of Columbia, 20016
GSK Investigational Site
Wilmington, Delaware, 19808
GSK Investigational Site
Woodstock, Vermont, 05091
About this study
Official title: A 7 Month, Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300 mg/Day of Extended-Release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
Read the detailed description
A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
- Conditions
- Depressive Disorder
- Being tested
- Extended-release Bupropion Hydrochloride
- Keywords
- Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder
- Medical subject headings
- Depressive Disorder, Seasonal Affective Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release Bupropion HydrochlorideDrug
Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Extended-release Bupropion Hydrochloride | Other | Extended-release Bupropion Hydrochloride Receives: Drug: Extended-release Bupropion Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of season depression-free rate.
Measured: 7 months
Secondary outcomes (1)
Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2003 (estimated)
- Study start23 Sep 2003
- Primary completion3 Jun 2004
- Study completion3 Jun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069459
- Sponsor's protocol ID
- 100006
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2003
- Last updated
- 25 Sep 2017
- Results posted
- No
Publications
Modell, JG, Rosenthal NE. Once-Daily Bupropion XL for the prevention of seasonal major depressive episodes. 43nd Annual Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico, 12-16 December, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 7 Month, Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300 mg/Day of Extended-Release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
- ClinicalTrials.gov ID
- NCT00069459
- Acronym / sponsor ID
- 100006
- Conditions
- Depressive Disorder
- Keywords
- Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2003 (actual)
- Primary completion
- 3 Jun 2004 (actual)
- Study completion
- 3 Jun 2004 (actual)
- First posted
- 26 Sep 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.
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
Detailed description
A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended-release Bupropion Hydrochloride | Other | Drug: Extended-release Bupropion HydrochlorideExtended-release Bupropion Hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of Major Depressive Disorder (MDD) with a seasonal pattern.
Key exclusion criteria (5 listed)
- Current or past history of seizure disorder or brain injury.
- History or current diagnosis of anorexia nervosa or bulimia.
- Recurrent summer depression more frequently than winter depression.
- Primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Post-traumatic Stress Disorder(PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- 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 HydrochlorideBupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride | Drug | Extended-release Bupropion Hydrochloride |
Primary outcome
End of season depression-free rate.
Time frame: 7 months
1 secondary outcome
Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.
Time frame: 7 months
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 25 Sep 2017.
- Results publicationModell, JG, Rosenthal NE. Once-Daily Bupropion XL for the prevention of seasonal major depressive episodes. 43nd Annual Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico, 12-16 December, 2004.
- Results for study 100006 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 study director
GlaxoSmithKline
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extended-release Bupropion Hydrochloride in people with Depressive Disorder, run by GlaxoSmithKline at 48 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
End of season depression-free rate. (time frame: 7 months). 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 NCT00069459, which also lists 1 linked publication.
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 25 Sep 2017.