Major Depressive Disorder In The Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093288
Recruitment Status : Completed
First Posted : October 7, 2004
Last Update Posted : September 2, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: bupropion XL Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 2004
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093288

Australia, Queensland
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
GSK Investigational Site
Everton Park, Queensland, Australia, 4053
GSK Investigational Site
New Farm, Queensland, Australia, 4005
Australia, Victoria
GSK Investigational Site
St. Albans, Victoria, Australia, 3021
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Mont-Godinne, Belgium, 5530
GSK Investigational Site
Montignies-sur-Sambre, Belgium, 6061
GSK Investigational Site
Mikkeli, Finland, 50100
GSK Investigational Site
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
Oslo, Norway, 0407
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
Moscow, Russian Federation, 119992
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00093288     History of Changes
Other Study ID Numbers: AK130940
First Posted: October 7, 2004    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors