Clinical trial NCT00046241: Prevention of Seasonal Affective Disorder
Official title: A 7 Month, Multicenter, Randomized, Double-blind, Placebo-controlled Comparison of 150-300mg/Day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in Subjects With a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Affective Disorder
Keywords: seasonal depression winter blues winter depression
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-09-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).


Eligibility criteria: Inclusion Criteria:

* Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.

Exclusion Criteria:

* Patient has a current or past history of seizure disorder or brain injury.
* Patient has a history or current diagnosis of anorexia nervosa 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.

Primary outcomes:
measure: Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
Secondary outcomes:
measure: Change in HAMD-24 and -17 total score. Change in pain score.
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: GSK Clinical Trials Call Center
state: Alaska
city: Hamden
country: United States
facility: GSK Clinical Trials Call Center
state: Connecticut
city: Boise
country: United States
facility: GSK Clinical Trials Call Center
state: Idaho
city: Chicago
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Edwardsville
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Oak Brook
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Oakbrook Terrace
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Lafayette
country: United States
facility: GSK Clinical Trials Call Center
state: Indiana
city: Cedar Rapids
country: United States
facility: GSK Clinical Trials Call Center
state: Iowa
city: Overland Park
country: United States
facility: GSK Clinical Trials Call Center
state: Kansas
city: Baltimore
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Rockville
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Belmont
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Detroit
country: United States
facility: GSK Clinical Trials Call Center
state: Michigan
city: Farmington Hills
country: United States
facility: GSK Clinical Trials Call Center
state: Michigan
city: Minneapolis
country: United States
facility: GSK Clinical Trials Call Center
state: Minnesota
city: St. Louis
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: Omaha
country: United States
facility: GSK Clinical Trials Call Center
state: Nebraska
city: Clementon
country: United States
facility: GSK Clinical Trials Call Center
state: New Jersey
city: Kenilworth
country: United States
facility: GSK Clinical Trials Call Center
state: New Jersey
city: Princeton
country: United States
facility: GSK Clinical Trials Call Center
state: New Jersey
city: Albany
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: New York
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Rochester
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Beachwood
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Cincinnati
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Dayton
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Marion
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Eugene
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Portland
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Portland
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Havertown
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Jenkintown
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Clinical Trials Call Center
state: Rhode Island
city: Woodstock
country: United States
facility: GSK Clinical Trials Call Center
state: Vermont
city: Falls Church
country: United States
facility: GSK Clinical Trials Call Center
state: Virginia
city: Bellevue
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Seattle
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Spokane
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Brown Deer
country: United States
facility: GSK Clinical Trials Call Center
state: Wisconsin
city: Calgary
country: Canada
facility: GSK Clinical Trials Call Center
state: Alberta
city: Edmonton
country: Canada
facility: GSK Clinical Trials Call Center
state: Alberta
city: Kelowna
country: Canada
facility: GSK Clinical Trials Call Center
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Clinical Trials Call Center
state: Manitoba
city: Toronto
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Toronto
country: Canada
facility: GSK Clinical Trials Call Center
state: Ontario
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trial, MD
role: STUDY_DIRECTOR
References: