Major Depressive Disorder In The Elderly

August 29, 2013 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

364

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Caboolture, Queensland, Australia, 4510
        • GSK Investigational Site
      • Everton Park, Queensland, Australia, 4053
        • GSK Investigational Site
      • New Farm, Queensland, Australia, 4005
        • GSK Investigational Site
    • Victoria
      • St. Albans, Victoria, Australia, 3021
        • GSK Investigational Site
  • Belgium
      • Liège, Belgium, 4000
        • GSK Investigational Site
      • Mont-Godinne, Belgium, 5530
        • GSK Investigational Site
      • Montignies-sur-Sambre, Belgium, 6061
        • GSK Investigational Site
  • Finland
      • Mikkeli, Finland, 50100
        • GSK Investigational Site
  • Netherlands
      • Amersfoort, Netherlands, 3818 ES
        • GSK Investigational Site
      • Grubbenvorst, Netherlands, 5971 BB
        • GSK Investigational Site
      • Hilversum, Netherlands, 1211 PA
        • GSK Investigational Site
      • Hoogvliet, Netherlands, 3192 JN
        • GSK Investigational Site
      • Wildervank, Netherlands, 9648 BE
        • GSK Investigational Site
  • Norway
      • Oslo, Norway, 0407
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • GSK Investigational Site
      • Moscow, Russian Federation, 119992
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

October 5, 2004

First Submitted That Met QC Criteria

October 6, 2004

First Posted (Estimate)

October 7, 2004

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK130940

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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