Prevention of Seasonal Affective Disorder - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00046241

Purpose

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).

Condition	Intervention	Phase
Seasonal Affective Disorder	Drug: Extended-release bupropion hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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:

Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.

Secondary Outcome Measures:

Change in HAMD-24 and -17 total score. Change in pain score.

Estimated Enrollment:	300
Study Start Date:	September 2002

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046241

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Locations

United States, Alaska
GSK Clinical Trials Call Center
Anchorage, Alaska, United States, 99508
United States, Connecticut
GSK Clinical Trials Call Center
Hamden, Connecticut, United States, 06518
United States, Idaho
GSK Clinical Trials Call Center
Boise, Idaho, United States, 83702
United States, Illinois
GSK Clinical Trials Call Center
Oakbrook Terrace, Illinois, United States, 60181
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60637
GSK Clinical Trials Call Center
Edwardsville, Illinois, United States, 62025
GSK Clinical Trials Call Center
Oak Brook, Illinois, United States, 60523
United States, Indiana
GSK Clinical Trials Call Center
Lafayette, Indiana, United States, 47905
United States, Iowa
GSK Clinical Trials Call Center
Cedar Rapids, Iowa, United States, 52401
United States, Kansas
GSK Clinical Trials Call Center
Overland Park, Kansas, United States, 66211
United States, Maryland
GSK Clinical Trials Call Center
Baltimore, Maryland, United States, 21204
GSK Clinical Trials Call Center
Rockville, Maryland, United States, 20852
GSK Clinical Trials Call Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
GSK Clinical Trials Call Center
Belmont, Massachusetts, United States, 02478
United States, Michigan
GSK Clinical Trials Call Center
Farmington Hills, Michigan, United States, 48334
GSK Clinical Trials Call Center
Detroit, Michigan, United States, 48207
GSK Clinical Trials Call Center
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
GSK Clinical Trials Call Center
Minneapolis, Minnesota, United States, 55454
United States, Missouri
GSK Clinical Trials Call Center
St. Louis, Missouri, United States, 63108
United States, Nebraska
GSK Clinical Trials Call Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
GSK Clinical Trials Call Center
Clementon, New Jersey, United States, 08021
GSK Clinical Trials Call Center
Princeton, New Jersey, United States, 08540
GSK Clinical Trials Call Center
Kenilworth, New Jersey, United States, 07033
United States, New York
GSK Clinical Trials Call Center
Albany, New York, United States, 12208
GSK Clinical Trials Call Center
New York, New York, United States, 10025
GSK Clinical Trials Call Center
New York, New York, United States, 10024
GSK Clinical Trials Call Center
New York, New York, United States, 10021
GSK Clinical Trials Call Center
Rochester, New York, United States, 14618
United States, Ohio
GSK Clinical Trials Call Center
Marion, Ohio, United States, 43302
GSK Clinical Trials Call Center
Dayton, Ohio, United States, 45415
GSK Clinical Trials Call Center
Cincinnati, Ohio, United States, 45267
GSK Clinical Trials Call Center
Beachwood, Ohio, United States, 44122
United States, Oregon
GSK Clinical Trials Call Center
Eugene, Oregon, United States, 97401
GSK Clinical Trials Call Center
Eugene, Oregon, United States, 97401
GSK Clinical Trials Call Center
Portland, Oregon, United States, 97239
GSK Clinical Trials Call Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, United States, 19131
GSK Clinical Trials Call Center
Havertown, Pennsylvania, United States, 19083
GSK Clinical Trials Call Center
Jenkintown, Pennsylvania, United States, 19046
United States, Rhode Island
GSK Clinical Trials Call Center
East Providence, Rhode Island, United States, 02915
United States, Vermont
GSK Clinical Trials Call Center
Woodstock, Vermont, United States, 05091
United States, Virginia
GSK Clinical Trials Call Center
Falls Church, Virginia, United States, 22041
United States, Washington
GSK Clinical Trials Call Center
Seattle, Washington, United States, 98105
GSK Clinical Trials Call Center
Spokane, Washington, United States, 99204
GSK Clinical Trials Call Center
Bellevue, Washington, United States, 98004
United States, Wisconsin
GSK Clinical Trials Call Center
Brown Deer, Wisconsin, United States, 53223
Canada, Alberta
GSK Clinical Trials Call Center
Calgary, Alberta, Canada, T2X 2A8
GSK Clinical Trials Call Center
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
GSK Clinical Trials Call Center
Kelowna, British Columbia, Canada, V1Y 2A3
Canada, Manitoba
GSK Clinical Trials Call Center
Winnipeg, Manitoba, Canada, R3E 3N4
Canada, Ontario
GSK Clinical Trials Call Center
Toronto, Ontario, Canada, M9W 4L6
GSK Clinical Trials Call Center
Toronto, Ontario, Canada, M4T 1K2
Canada, Quebec
GSK Clinical Trials Call Center
Sherbrooke, Quebec, Canada, J1G 1W4
GSK Clinical Trials Call Center
Montreal, Quebec, Canada, H2L 1H9

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	AK130930
Study First Received:	September 24, 2002
Last Updated:	March 6, 2006
ClinicalTrials.gov Identifier:	NCT00046241 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

seasonal depression winter blues winter depression

Additional relevant MeSH terms:

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

Pathologic Processes
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 27, 2009