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

GlaxoSmithKline1 site in 1 country300 target enrollmentSeptember 2002

ConditionsSeasonal Affective Disorder

DrugsExtended-release bupropion hydrochloride

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Seasonal Affective Disorder
Sponsor: GlaxoSmithKline
Enrollment: 300
Locations: 1
Primary Endpoint: Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2002

End Date

June 2003

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

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.