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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00069459
Other study ID # 100006
Secondary ID
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
Health authority
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.

Study Design


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
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