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

GlaxoSmithKline1 site in 1 country250 target enrollmentSeptember 23, 2003

ConditionsDepressive Disorder

InterventionsExtended-release Bupropion Hydrochloride

DrugsExtended-release Bupropion Hydrochloride

Overview

Phase: Phase 1
Intervention: Extended-release Bupropion Hydrochloride
Conditions: Depressive Disorder
Sponsor: GlaxoSmithKline
Enrollment: 250
Locations: 1
Primary Endpoint: End of season depression-free rate.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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

Registry

clinicaltrials.gov

Start Date

September 23, 2003

End Date

June 3, 2004

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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.