Seasonal Affective Depression (SAD) Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 25, 2003

Last Updated Date

May 15, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

End of season depression-free rate.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00069459 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to onset of a seasonal depressive episode. Change from randomization on SIGH-SAD and HAMD-17.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Seasonal Affective Depression (SAD) Study

Official Title ^ICMJE

See Detailed Description

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Seasonal Affective Disorder (SAD)

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

250

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

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

Administrative Information

NCT ID ^ICMJE

NCT00069459

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

100006

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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