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Prevention of Seasonal Affective Disorder

Primary Purpose

Seasonal Affective Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Extended-release bupropion hydrochloride
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring seasonal depression winter blues winter depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center

Outcomes

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.

Full Information

First Posted
September 24, 2002
Last Updated
January 20, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00046241
Brief Title
Prevention of Seasonal Affective Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (Actual)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
Keywords
seasonal depression winter blues winter depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Extended-release bupropion hydrochloride
Primary Outcome Measure Information:
Title
Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
Secondary Outcome Measure Information:
Title
Change in HAMD-24 and -17 total score. Change in pain score.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trial, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Edwardsville
State/Province
Illinois
ZIP/Postal Code
62025
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52401
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2X 2A8
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2A3
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3N4
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4T 1K2
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1H9
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 1W4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Prevention of Seasonal Affective Disorder

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