Major Depressive Disorder In The Elderly

This study has been completed.

First Received: October 5, 2004 Last Updated: May 15, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00093288

Purpose

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

Condition	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: bupropion XL	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures:

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

Estimated Enrollment:	364
Study Start Date:	June 2004

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093288

Show 97 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AK130940
Study First Received:	October 5, 2004
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00093288 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Depression
MDD
bupropion

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Pharmacologic Actions

Behavioral Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
Bupropion
Mood Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2009