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Prevention of Seasonal Affective Disorder

Primary Purpose

Seasonal Affective Disorder (SAD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Investigational Seasonal Affective Disorder (SAD) Drug
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder (SAD)

Eligibility Criteria

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

Inclusion Criteria: (Patient must meet these criteria in order to be eligible for this study.) Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern. Exclusion Criteria: (Patient cannot meet these criteria in order to be eligible for this study.) Patient has a current or past history of seizure disorder or brain injury. Patient has a history or current diagnosis of anorexia nervousa 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.

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Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 30, 2002
Last Updated
June 2, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00046449
Brief Title
Prevention of Seasonal Affective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
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
A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder (SAD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Investigational Seasonal Affective Disorder (SAD) Drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (Patient must meet these criteria in order to be eligible for this study.) Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern. Exclusion Criteria: (Patient cannot meet these criteria in order to be eligible for this study.) Patient has a current or past history of seizure disorder or brain injury. Patient has a history or current diagnosis of anorexia nervousa 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.
Facility Information:
Facility Name
Study Site
City
Homer
State/Province
Alaska
ZIP/Postal Code
99603
Country
United States
Facility Name
Study Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504-0605
Country
United States
Facility Name
Study Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Study Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19808-1251
Country
United States
Facility Name
Study Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Study Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Study Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Study SIte
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Study Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Study Site
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Study SIte
City
Northfield
State/Province
Illinois
ZIP/Postal Code
60093
Country
United States
Facility Name
Study Site
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Study SIte
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Study Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
45202
Country
United States
Facility Name
Study Site
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Study Site
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Study Site
City
Okemos
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Facility Name
Study Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48067
Country
United States
Facility Name
Study Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Study Site
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Study Site
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Study Site
City
Amityville
State/Province
New York
ZIP/Postal Code
11701
Country
United States
Facility Name
Study Site
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
Facility Name
Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Study Site
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
Facility Name
Study Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Study Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Study Site
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Study Site
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Study Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Study Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Study Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97309
Country
United States
Facility Name
Study Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Study Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865-4208
Country
United States
Facility Name
Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Study Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States
Facility Name
Study Site
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Study Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Study Site
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Study Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Study Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Study Site
City
Miramichi
State/Province
New Brunswick
ZIP/Postal Code
E1V 3G5
Country
Canada
Facility Name
Study Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1S 2E8
Country
Canada
Facility Name
Study Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
Facility Name
Study Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada
Facility Name
Study Site
City
Hull
State/Province
Quebec
ZIP/Postal Code
J9A 1K7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Prevention of Seasonal Affective Disorder

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