Seasonal Affective Depression (SAD) Study - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00069459

Purpose

A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder

Condition	Intervention	Phase
Seasonal Affective Disorder (SAD)	Drug: Extended-release Bupropion Hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Depression Seasonal Affective Disorder

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

End of season depression-free rate.

Secondary Outcome Measures:

Time to onset of a seasonal depressive episode. Change from randomization on SIGH-SAD and HAMD-17.

Estimated Enrollment:	250
Study Start Date:	September 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069459

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Locations

United States, Connecticut
GSK Investigational Site
Hamden, Connecticut, United States, 06518
United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19713
GSK Investigational Site
Wilmington, Delaware, United States, 19808
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20016
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83702
United States, Illinois
GSK Investigational Site
Hoffman Estates, Illinois, United States, 60194
GSK Investigational Site
Northfield, Illinois, United States, 60093
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
GSK Investigational Site
Edwardsville, Illinois, United States, 62025
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
United States, Iowa
GSK Investigational Site
Cedar Rapids, Iowa, United States, 52401
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21204
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
GSK Investigational Site
Belmont, Massachusetts, United States, 02478
United States, Michigan
GSK Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63108
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68198
United States, New Jersey
GSK Investigational Site
Piscataway, New Jersey, United States, 08854
GSK Investigational Site
Princeton, New Jersey, United States, 08540
GSK Investigational Site
Kenilworth, New Jersey, United States, 07033
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14618
GSK Investigational Site
Lawrence, New York, United States, 11559
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
New York, New York, United States, 10128
GSK Investigational Site
Albany, New York, United States, 12208
GSK Investigational Site
New York, New York, United States, 10032
United States, Ohio
GSK Investigational Site
Concinnati, Ohio, United States, 45219
GSK Investigational Site
Columbus, Ohio, United States, 43210
GSK Investigational Site
Lyndhurst, Ohio, United States, 44124
GSK Investigational Site
Toledo, Ohio, United States, 43623
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Portland, Oregon, United States, 97210
GSK Investigational Site
Portland, Oregon, United States, 97209
GSK Investigational Site
Portland, Oregon, United States, 97201
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18104
GSK Investigational Site
Havertown, Pennsylvania, United States, 19083
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
United States, Rhode Island
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
United States, Vermont
GSK Investigational Site
Woodstock, Vermont, United States, 05091
United States, Washington
GSK Investigational Site
Spokane, Washington, United States, 99204
United States, Wisconsin
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
GSK Investigational Site
Menomonee Falls, Wisconsin, United States, 53051
GSK Investigational Site
Madison, Wisconsin, United States, 53719
GSK Investigational Site
Middleton, Wisconsin, United States, 53562-2215

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100006
Study First Received:	September 25, 2003
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00069459 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Pharmacologic Actions
Seasonal Affective Disorder

Mental Disorders
Therapeutic Uses
Bupropion
Mood Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 25, 2009