Seasonal Affective Depression (SAD) Study

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069459
• Other study ID #: 100006
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2003
• Last updated: September 21, 2017
• Start date: September 23, 2003
• Est. completion date: June 3, 2004

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 3, 2004
• Est. primary completion date: June 3, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Mood Disorders
• Seasonal Affective Disorder

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Allentown	Pennsylvania
United States	GSK Investigational Site	Anchorage	Alaska
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Belmont	Massachusetts
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Brown Deer	Wisconsin
United States	GSK Investigational Site	Cedar Rapids	Iowa
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Edwardsville	Illinois
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Farmington Hills	Michigan
United States	GSK Investigational Site	Hamden	Connecticut
United States	GSK Investigational Site	Havertown	Pennsylvania
United States	GSK Investigational Site	Hoffman Estates	Illinois
United States	GSK Investigational Site	Kenilworth	New Jersey
United States	GSK Investigational Site	Lawrence	New York
United States	GSK Investigational Site	Lincoln	Rhode Island
United States	GSK Investigational Site	Lyndhurst	Ohio
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Menomonee Falls	Wisconsin
United States	GSK Investigational Site	Middleton	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Moorestown	New Jersey
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	Delaware
United States	GSK Investigational Site	Northfield	Illinois
United States	GSK Investigational Site	Oak Brook	Illinois
United States	GSK Investigational Site	Oakbrook Terrace	Illinois
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Piscataway	New Jersey
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Princeton	New Jersey
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Washington, D.C.	District of Columbia
United States	GSK Investigational Site	Wilmington	Delaware
United States	GSK Investigational Site	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of season depression-free rate.		7 months
Secondary	Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17.		7 months

External Links

•   Results for study 100006 can be found on the GSK Clinical Study Register.