Last updated: 11/02/2018 22:50:27

Seasonal Affective Depression (SAD) Study

GSK study ID
100006
See study documents
Clinicaltrials.gov ID
NCT00069459
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Status
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lawrence, New York, United States, 11559
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Northfield, Illinois, United States, 60093
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Woodstock, Vermont, United States, 05091
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kenilworth, New Jersey, United States, 07033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14618
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oakbrook Terrace, Illinois, United States, 60181
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anchorage, Alaska, United States, 99508
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cedar Rapids, Iowa, United States, 52401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Eugene, Oregon, United States, 97401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10032
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hoffman Estates, Illinois, United States, 60194
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20016
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rockville, Maryland, United States, 20852
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43623
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Farmington Hills, Michigan, United States, 48334
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Middleton, Wisconsin, United States, 53562-2215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Havertown, Pennsylvania, United States, 19083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Edwardsville, Illinois, United States, 62025
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Concinnati, Ohio, United States, 45219
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68198
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newark, Delaware, United States, 19713
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53719
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oak Brook, Illinois, United States, 60523
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55454
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wilmington, Delaware, United States, 19808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamden, Connecticut, United States, 06518
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Menomonee Falls, Wisconsin, United States, 53051
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albany, New York, United States, 12208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brown Deer, Wisconsin, United States, 53223
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Belmont, Massachusetts, United States, 02478
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Piscataway, New Jersey, United States, 08854
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Moorestown, New Jersey, United States, 08057
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Princeton, New Jersey, United States, 08540
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lyndhurst, Ohio, United States, 44124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lincoln, Rhode Island, United States, 02865-4208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Allentown, Pennsylvania, United States, 18104
    Status
    Study Complete
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    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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

    Participate in clinical trial
    Additional information
    Results for study 100006 can be found on the GSK Clinical Study Register.
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    Access to clinical trial data by researchers
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