Last updated: 11/02/2018 22:50:27
Seasonal Affective Depression (SAD) Study
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
End of season depression-free rate.
Timeframe: 7 months
Secondary outcomes:
Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.
Timeframe: 7 months
Interventions:
Drug: Extended-release Bupropion Hydrochloride
Enrollment:
250
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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.
Medical condition
Depressive Disorder
Product
bupropion
Collaborators
Not applicable
Study date(s)
September 2003 to June 2004
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- History of Major Depressive Disorder (MDD) with a seasonal pattern.
- Current or past history of seizure disorder or brain injury.
- History or current diagnosis of anorexia nervosa or bulimia.
Inclusion and exclusion criteria
Inclusion criteria:
- History of Major Depressive Disorder (MDD) with a seasonal pattern.
Exclusion criteria:
- 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 location(s)
Location
GSK Investigational Site
Portland, Oregon, United States, 97209
Status
Study Complete
Location
GSK Investigational Site
Lawrence, New York, United States, 11559
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63108
Status
Study Complete
Location
GSK Investigational Site
Northfield, Illinois, United States, 60093
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Vermont, United States, 05091
Status
Study Complete
Location
GSK Investigational Site
Kenilworth, New Jersey, United States, 07033
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
Location
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
Status
Study Complete
Location
GSK Investigational Site
Anchorage, Alaska, United States, 99508
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cedar Rapids, Iowa, United States, 52401
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Hoffman Estates, Illinois, United States, 60194
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20016
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Farmington Hills, Michigan, United States, 48334
Status
Study Complete
Location
GSK Investigational Site
Middleton, Wisconsin, United States, 53562-2215
Status
Study Complete
Location
GSK Investigational Site
Havertown, Pennsylvania, United States, 19083
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
Status
Study Complete
Location
GSK Investigational Site
Edwardsville, Illinois, United States, 62025
Status
Study Complete
Location
GSK Investigational Site
Concinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Newark, Delaware, United States, 19713
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53719
Status
Study Complete
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97201
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
Status
Study Complete
Location
GSK Investigational Site
Wilmington, Delaware, United States, 19808
Status
Study Complete
Location
GSK Investigational Site
Hamden, Connecticut, United States, 06518
Status
Study Complete
Location
GSK Investigational Site
Menomonee Falls, Wisconsin, United States, 53051
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Study Complete
Location
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10128
Status
Study Complete
Location
GSK Investigational Site
Belmont, Massachusetts, United States, 02478
Status
Study Complete
Location
GSK Investigational Site
Piscataway, New Jersey, United States, 08854
Status
Study Complete
Location
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
Status
Study Complete
Location
GSK Investigational Site
Princeton, New Jersey, United States, 08540
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18104
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-03-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 100006 can be found on the GSK Clinical Study Register.
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