Prevention of Seasonal Affective Disorder

January 20, 2017 updated by: GlaxoSmithKline

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trial, MD, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

September 24, 2002

First Submitted That Met QC Criteria

September 24, 2002

First Posted (Estimate)

September 25, 2002

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK130930

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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