Seasonal Affective Depression (SAD) Study
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
1 other identifier
interventional
250
1 country
48
Brief Summary
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2003
Shorter than P25 for phase_1
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2003
CompletedFirst Submitted
Initial submission to the registry
September 25, 2003
CompletedFirst Posted
Study publicly available on registry
September 26, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2004
CompletedSeptember 25, 2017
September 1, 2017
8 months
September 25, 2003
September 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
End of season depression-free rate.
7 months
Secondary Outcomes (1)
Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.
7 months
Study Arms (1)
Extended-release Bupropion Hydrochloride
OTHERExtended-release Bupropion Hydrochloride
Interventions
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
Eligibility Criteria
You may qualify if:
- History of Major Depressive Disorder (MDD) with a seasonal pattern.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (48)
GSK Investigational Site
Anchorage, Alaska, 99508, United States
GSK Investigational Site
Hamden, Connecticut, 06518, United States
GSK Investigational Site
Newark, Delaware, 19713, United States
GSK Investigational Site
Wilmington, Delaware, 19808, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20016, United States
GSK Investigational Site
Boise, Idaho, 83702, United States
GSK Investigational Site
Edwardsville, Illinois, 62025, United States
GSK Investigational Site
Hoffman Estates, Illinois, 60194, United States
GSK Investigational Site
Northfield, Illinois, 60093, United States
GSK Investigational Site
Oak Brook, Illinois, 60523, United States
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181, United States
GSK Investigational Site
Cedar Rapids, Iowa, 52401, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Baltimore, Maryland, 21204, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Belmont, Massachusetts, 02478, United States
GSK Investigational Site
Farmington Hills, Michigan, 48334, United States
GSK Investigational Site
Minneapolis, Minnesota, 55454, United States
GSK Investigational Site
St Louis, Missouri, 63108, United States
GSK Investigational Site
Omaha, Nebraska, 68198, United States
GSK Investigational Site
Kenilworth, New Jersey, 07033, United States
GSK Investigational Site
Moorestown, New Jersey, 08057, United States
GSK Investigational Site
Piscataway, New Jersey, 08854, United States
GSK Investigational Site
Princeton, New Jersey, 08540, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Lawrence, New York, 11559, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
New York, New York, 10128, United States
GSK Investigational Site
Rochester, New York, 14618, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Columbus, Ohio, 43210, United States
GSK Investigational Site
Lyndhurst, Ohio, 44124, United States
GSK Investigational Site
Toledo, Ohio, 43623, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Portland, Oregon, 97201, United States
GSK Investigational Site
Portland, Oregon, 97209, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Allentown, Pennsylvania, 18104, United States
GSK Investigational Site
Havertown, Pennsylvania, 19083, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19106, United States
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208, United States
GSK Investigational Site
Woodstock, Vermont, 05091, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Brown Deer, Wisconsin, 53223, United States
GSK Investigational Site
Madison, Wisconsin, 53719, United States
GSK Investigational Site
Menomonee Falls, Wisconsin, 53051, United States
GSK Investigational Site
Middleton, Wisconsin, 53562-2215, United States
Related Publications (1)
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.
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2003
First Posted
September 26, 2003
Study Start
September 23, 2003
Primary Completion
June 3, 2004
Study Completion
June 3, 2004
Last Updated
September 25, 2017
Record last verified: 2017-09