Seasonal Affective Disorder (SAD)Phase 3NCT00046449
Prevention of Seasonal Affective Disorder
A Phase 3 study testing Investigational Seasonal Affective Disorder (SAD) Drug in people with Seasonal Affective Disorder (SAD), run by GlaxoSmithKline at 54 sites in 2 countries.
Trial summary
A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Affective Disorder (SAD)
- What is being tested?
- Investigational Seasonal Affective Disorder (SAD) Drug
- How many people
- Not given
- Where
- 54 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
Inclusion Criteria: (Patient must meet these criteria in order to be eligible for this study.)
- Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.
Exclusion Criteria: (Patient cannot meet these criteria in order to be eligible for this study.)
- Patient has a current or past history of seizure disorder or brain injury.
- Patient has a history or current diagnosis of anorexia nervousa 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
54 sites in 2 countries.
54 sites in 2 countries
United States47 sites
Study Site
Allentown, Pennsylvania, 18104
Study Site
Amityville, New York, 11701
Study Site
Boise, Idaho, 83704
Study SIte
Chicago, Illinois, 60610
Study Site
Chicago, Illinois, 60612
Study Site
Cincinnati, Ohio, 45219
Study Site
Cleveland, Ohio, 44106
Study Site
Cleveland, Ohio, 44121
Study Site
Eugene, Oregon, 97401
Study Site
Florence, Kentucky, 41042
Study SIte
Greenwood, Indiana, 46143
Study Site
Hoffman Estates, Illinois, 60194
Study Site
Homer, Alaska, 99603
Study Site
Independence, Ohio, 44131
Study Site
Indianapolis, Indiana, 45202
Study Site
Lawrence, New York, 11559
Study Site
Libertyville, Illinois, 60048
Study Site
Lincoln, Rhode Island, 02865-4208
Study Site
Lyndhurst, Ohio, 44124
Study Site
Madison, Wisconsin, 53719
Study Site
Middleton, Wisconsin, 53562
Study Site
Milwaukee, Wisconsin, 53226
Study Site
Minneapolis, Minnesota, 55454
Study Site
Moorestown, New Jersey, 08057
Study Site
New Haven, Connecticut, 06504-0605
Study Site
New York, New York, 10021
Study Site
Newark, Delaware, 19713
Study SIte
Northfield, Illinois, 60093
Study Site
Okemos, Michigan, 48864
Study Site
Olean, New York, 14760
Study Site
Philadelphia, Pennsylvania, 19106
Study Site
Philadelphia, Pennsylvania, 19107
Study Site
Piscataway, New Jersey, 08854
Study Site
Portland, Oregon, 97201
Study Site
Portland, Oregon, 97209
Study Site
Royal Oak, Michigan, 48067
Study Site
Salem, Oregon, 97309
Study Site
Schaumburg, Illinois, 60194
Study Site
Seattle, Washington, 98104
Study Site
Staten Island, New York, 10305
Study Site
Toledo, Ohio, 43623
Study Site
Washington D.C., District of Columbia, 20016
Study Site
Washington D.C., District of Columbia, 20037
Study Site
Wellesley Hills, Massachusetts, 02481
Study Site
West Allis, Wisconsin, 53227
Study Site
Williamsville, New York, 14221
Study Site
Wilmington, Delaware, 19808-1251
Canada7 sites
Study Site
Edmonton, Alberta, T6G 2C8
Study Site
Hull, Quebec, J9A 1K7
Study Site
Markham, Ontario, L6B 1A1
Study Site
Miramichi, New Brunswick, E1V 3G5
Study Site
Mississauga, Ontario, L4W 1N2
Study Site
Sydney, Nova Scotia, B1S 2E8
Study Site
Vancouver, British Columbia, V6Z 1Y6
About this study
A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder
- Conditions
- Seasonal Affective Disorder (SAD)
- Being tested
- Investigational Seasonal Affective Disorder (SAD) Drug
- 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.
Investigational Seasonal Affective Disorder (SAD) DrugDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 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 Disorder (SAD)Studies 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
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046449
- Sponsor's protocol ID
- 398149
- Status last verified
- Jun 2015
- First submitted
- 30 Sep 2002
- Last updated
- 4 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Seasonal Affective Disorder
- ClinicalTrials.gov ID
- NCT00046449
- Acronym / sponsor ID
- 398149
- Conditions
- Seasonal Affective Disorder (SAD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 2 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.
A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder
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
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 |
|---|---|---|
| Investigational Seasonal Affective Disorder (SAD) Drug | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Jun 2015.
Related trials for Seasonal Affective Disorder (SAD)
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Seasonal Affective Disorder (SAD)
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.
The record lists no contact. Use the official record to reach the sponsor.
54 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 Investigational Seasonal Affective Disorder (SAD) Drug in people with Seasonal Affective Disorder (SAD), run by GlaxoSmithKline at 54 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?
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 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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.
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 4 Jun 2015.