Major Depressive Disorder In The Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00093288
First received: October 5, 2004
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Depressive Disorder, Major
Drug: bupropion XL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bupropion XL
    Other Name: bupropion XL
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Belgium
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Mont-Godinne, Belgium, 5530
GSK Investigational Site
Montignies-sur-Sambre, Belgium, 6061
Finland
GSK Investigational Site
Mikkeli, Finland, 50100
Netherlands
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
Norway
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00093288     History of Changes
Other Study ID Numbers: AK130940
Study First Received: October 5, 2004
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
MDD
bupropion
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014