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NCT00046241 Clinical Trial

Prevention of Seasonal Affective Disorder

Seasonal Affective Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00046241
Other study ID # AK130930
Secondary ID
Status Completed
Phase Phase 3
First received September 24, 2002
Last updated January 20, 2017
Start date September 2002
Est. completion date June 2003

Study information
Verified date January 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date June 2003
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Extended-release bupropion hydrochloride

Locations
Country Name City State
Canada GSK Clinical Trials Call Center Calgary Alberta
Canada GSK Clinical Trials Call Center Edmonton Alberta
Canada GSK Clinical Trials Call Center Kelowna British Columbia
Canada GSK Clinical Trials Call Center Montreal Quebec
Canada GSK Clinical Trials Call Center Sherbrooke Quebec
Canada GSK Clinical Trials Call Center Toronto Ontario
Canada GSK Clinical Trials Call Center Toronto Ontario
Canada GSK Clinical Trials Call Center Winnipeg Manitoba
United States GSK Clinical Trials Call Center Albany New York
United States GSK Clinical Trials Call Center Anchorage Alaska
United States GSK Clinical Trials Call Center Baltimore Maryland
United States GSK Clinical Trials Call Center Beachwood Ohio
United States GSK Clinical Trials Call Center Bellevue Washington
United States GSK Clinical Trials Call Center Belmont Massachusetts
United States GSK Clinical Trials Call Center Boise Idaho
United States GSK Clinical Trials Call Center Brown Deer Wisconsin
United States GSK Clinical Trials Call Center Cedar Rapids Iowa
United States GSK Clinical Trials Call Center Chicago Illinois
United States GSK Clinical Trials Call Center Cincinnati Ohio
United States GSK Clinical Trials Call Center Clementon New Jersey
United States GSK Clinical Trials Call Center Dayton Ohio
United States GSK Clinical Trials Call Center Detroit Michigan
United States GSK Clinical Trials Call Center East Providence Rhode Island
United States GSK Clinical Trials Call Center Edwardsville Illinois
United States GSK Clinical Trials Call Center Eugene Oregon
United States GSK Clinical Trials Call Center Falls Church Virginia
United States GSK Clinical Trials Call Center Farmington Hills Michigan
United States GSK Clinical Trials Call Center Hamden Connecticut
United States GSK Clinical Trials Call Center Havertown Pennsylvania
United States GSK Clinical Trials Call Center Jenkintown Pennsylvania
United States GSK Clinical Trials Call Center Kenilworth New Jersey
United States GSK Clinical Trials Call Center Lafayette Indiana
United States GSK Clinical Trials Call Center Marion Ohio
United States GSK Clinical Trials Call Center Minneapolis Minnesota
United States GSK Clinical Trials Call Center New York New York
United States GSK Clinical Trials Call Center New York New York
United States GSK Clinical Trials Call Center New York New York
United States GSK Clinical Trials Call Center Oak Brook Illinois
United States GSK Clinical Trials Call Center Oakbrook Terrace Illinois
United States GSK Clinical Trials Call Center Omaha Nebraska
United States GSK Clinical Trials Call Center Overland Park Kansas
United States GSK Clinical Trials Call Center Philadelphia Pennsylvania
United States GSK Clinical Trials Call Center Portland Oregon
United States GSK Clinical Trials Call Center Portland Oregon
United States GSK Clinical Trials Call Center Princeton New Jersey
United States GSK Clinical Trials Call Center Rochester New York
United States GSK Clinical Trials Call Center Rockville Maryland
United States GSK Clinical Trials Call Center Seattle Washington
United States GSK Clinical Trials Call Center Spokane Washington
United States GSK Clinical Trials Call Center St. Louis Missouri
United States GSK Clinical Trials Call Center Woodstock Vermont

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
Secondary Change in HAMD-24 and -17 total score. Change in pain score.
See also
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Recruiting NCT01030276 - Bright Light Therapy in Seasonal Affective Disorder (SAD) N/A
Completed NCT01292889 - Study of Genes in Relation to Seasonal Affective Disorder and Major Depressive Disorder N/A
Completed NCT01149135 - Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder N/A
Completed NCT01048294 - Blue Enriched Versus Standard Light Treatment for Seasonal Affective Disorder(SAD) N/A
Completed NCT02582398 - Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET N/A
Completed NCT01293409 - Bright Light Therapy in Seasonal Affective Disorder (SAD) N/A
Active, not recruiting NCT00269633 - Research Study of Treatment for Winter Depression With Different Colors of Light Phase 2
Completed NCT00076245 - Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD) Phase 1
Completed NCT03313674 - Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD N/A
Completed NCT00016666 - Clinical Trial of Propranolol for Seasonal Affective Disorder Phase 2
Recruiting NCT00114322 - Light-Emitting Diode (LED) Light for Seasonal Affective Disorder (SAD) Treatment N/A
Completed NCT00001485 - Effects of Season on Melatonin Secretion in Healthy Men and Women and Patients With Seasonal Affective Disorder N/A
Completed NCT01462305 - 30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder N/A
Completed NCT00139997 - Environmental Treatment for Seasonal Affective Disorder (SAD) N/A
Completed NCT04251000 - Infrared Photomodulation Therapy for Seasonal Affective Disorder N/A
Completed NCT00809523 - A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD) Phase 2/Phase 3