Clinical trial NCT00069459: Seasonal Affective Depression (SAD) Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder
Keywords: Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-09-26
Enrollment: 250
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: A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder

Detailed description: A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/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

Eligibility 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.

Primary outcomes:
measure: End of season depression-free rate.
timeFrame: 7 months
Secondary outcomes:
measure: Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.
timeFrame: 7 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: GSK Investigational Site
state: Alaska
city: Hamden
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Newark
country: United States
facility: GSK Investigational Site
state: Delaware
city: Wilmington
country: United States
facility: GSK Investigational Site
state: Delaware
city: Washington, D.C.
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Edwardsville
country: United States
facility: GSK Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: GSK Investigational Site
state: Illinois
city: Northfield
country: United States
facility: GSK Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: GSK Investigational Site
state: Illinois
city: Oakbrook Terrace
country: United States
facility: GSK Investigational Site
state: Illinois
city: Cedar Rapids
country: United States
facility: GSK Investigational Site
state: Iowa
city: Overland Park
country: United States
facility: GSK Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Belmont
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Kenilworth
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Moorestown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Piscataway
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Princeton
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Lawrence
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Lyndhurst
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Havertown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Vermont
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Brown Deer
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Menomonee Falls
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Middleton
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.