Seasonal Affective Depression (SAD) Study

September 21, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 1

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

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • GSK Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • GSK Investigational Site
      • Wilmington, Delaware, United States, 19808
        • GSK Investigational Site
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20016
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • GSK Investigational Site
    • Illinois
      • Edwardsville, Illinois, United States, 62025
        • 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
      • Oakbrook Terrace, Illinois, United States, 60181
        • GSK Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • GSK Investigational Site
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • GSK Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • GSK Investigational Site
    • New Jersey
      • Kenilworth, New Jersey, United States, 07033
        • GSK Investigational Site
      • Moorestown, New Jersey, United States, 08057
        • GSK Investigational Site
      • Piscataway, New Jersey, United States, 08854
        • GSK Investigational Site
      • Princeton, New Jersey, United States, 08540
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • GSK Investigational Site
      • Lawrence, New York, United States, 11559
        • GSK Investigational Site
      • New York, New York, United States, 10032
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10128
        • GSK Investigational Site
      • Rochester, New York, United States, 14618
        • GSK Investigational Site
    • Ohio
      • Cincinnati, 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
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Portland, Oregon, United States, 97201
        • GSK Investigational Site
      • Portland, Oregon, United States, 97209
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • GSK Investigational Site
      • Havertown, Pennsylvania, United States, 19083
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19106
        • GSK Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865-4208
        • GSK Investigational Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • GSK Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223
        • GSK Investigational Site
      • Madison, Wisconsin, United States, 53719
        • GSK Investigational Site
      • Menomonee Falls, Wisconsin, United States, 53051
        • GSK Investigational Site
      • Middleton, Wisconsin, United States, 53562-2215
        • GSK Investigational Site

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:

  • 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.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Extended-release Bupropion Hydrochloride
Drug: Extended-release Bupropion Hydrochloride
Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
End of season depression-free rate.
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.
Time Frame: 7 months
7 months

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

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 23, 2003

Primary Completion (Actual)

June 3, 2004

Study Completion (Actual)

June 3, 2004

Study Registration Dates

First Submitted

September 25, 2003

First Submitted That Met QC Criteria

September 25, 2003

First Posted (Estimate)

September 26, 2003

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100006

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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