Prevention of Seasonal Affective Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

September 24, 2002

Last Updated Date

March 6, 2006

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00046241 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in HAMD-24 and -17 total score. Change in pain score.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Prevention of Seasonal Affective Disorder

Official Title ^ICMJE

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

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).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Seasonal Affective Disorder

Intervention ^ICMJE

Drug: Extended-release bupropion hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00046241

Responsible Party

Study ID Numbers ^ICMJE

AK130930

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP