Major Depressive Disorder In The Elderly - Full Text View

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

MedlinePlus related topics:

Depression

Drug Information available for:

Bupropion hydrochloride Bupropion

U.S. FDA Resources

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

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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AK130940
First Received:	October 5, 2004
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00093288
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Depression

MDD

bupropion

Study placed in the following topic categories:

Dopamine

Depression

Mental Disorders

Bupropion

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Disease

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Dopamine Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2008

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