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Major Depressive Disorder In The Elderly

NCT ID: NCT00093288

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-10-31

Brief Summary

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

Detailed Description

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Conditions

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Depressive Disorder, Major

Keywords

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MDD bupropion Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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bupropion XL

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Caboolture, Queensland, Australia

Site Status

GSK Investigational Site

Everton Park, Queensland, Australia

Site Status

GSK Investigational Site

New Farm, Queensland, Australia

Site Status

GSK Investigational Site

St Albans, Victoria, Australia

Site Status

GSK Investigational Site

Liège, , Belgium

Site Status

GSK Investigational Site

Mont-Godinne, , Belgium

Site Status

GSK Investigational Site

Montignies-sur-Sambre, , Belgium

Site Status

GSK Investigational Site

Mikkeli, , Finland

Site Status

GSK Investigational Site

Amersfoort, , Netherlands

Site Status

GSK Investigational Site

Grubbenvorst, , Netherlands

Site Status

GSK Investigational Site

Hilversum, , Netherlands

Site Status

GSK Investigational Site

Hoogvliet, , Netherlands

Site Status

GSK Investigational Site

Wildervank, , Netherlands

Site Status

GSK Investigational Site

Oslo, , Norway

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

Countries

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

Other Identifiers

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AK130940

Identifier Type: -

Identifier Source: org_study_id