Major Depressive Disorder In The Elderly - Tabular View

Tracking Information

First Received Date ^ICMJE

October 5, 2004

Last Updated Date

May 15, 2009

Start Date ^ICMJE

June 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Montgomery-Asberg Depression Rating Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00093288 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Major Depressive Disorder In The Elderly

Official Title ^ICMJE

A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible Dose Study to Evaluate the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg-300mg Once Daily) in Elderly Subjects With Major Depressive Disorder

Brief Summary

This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Major Depressive Disorder (MDD)

Intervention ^ICMJE

Drug: bupropion XL

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

364

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks.

Exclusion Criteria:

Patient has current or past history of seizure disorder or brain injury.
Patient has a diagnosis of anorexia or bulimia within the past 12 months.
Patient has a past or current DMS-IV diagnosis of schizophrenia or any other psychotic disorder(s).
Patient has had a myocardial infarction within 1 year or a history of uncontrolled hypertension or unstable heart disease with 6 months.

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, Croatia, Finland, France, Germany, India, Latvia, Netherlands, Norway, Poland, Russian Federation, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00093288

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

AK130940

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