Major Depressive Disorder In The Elderly
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
1 other identifier
interventional
364
6 countries
16
Brief Summary
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2004
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 5, 2004
CompletedFirst Posted
Study publicly available on registry
October 7, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedSeptember 2, 2013
August 1, 2013
1.3 years
October 5, 2004
August 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery-Asberg Depression Rating Scale
Secondary Outcomes (1)
Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale
Interventions
Eligibility Criteria
You may qualify if:
- Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (16)
GSK Investigational Site
Caboolture, Queensland, 4510, Australia
GSK Investigational Site
Everton Park, Queensland, 4053, Australia
GSK Investigational Site
New Farm, Queensland, 4005, Australia
GSK Investigational Site
St Albans, Victoria, 3021, Australia
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Mont-Godinne, 5530, Belgium
GSK Investigational Site
Montignies-sur-Sambre, 6061, Belgium
GSK Investigational Site
Mikkeli, 50100, Finland
GSK Investigational Site
Amersfoort, 3818 ES, Netherlands
GSK Investigational Site
Grubbenvorst, 5971 BB, Netherlands
GSK Investigational Site
Hilversum, 1211 PA, Netherlands
GSK Investigational Site
Hoogvliet, 3192 JN, Netherlands
GSK Investigational Site
Wildervank, 9648 BE, Netherlands
GSK Investigational Site
Oslo, 0407, Norway
GSK Investigational Site
Moscow, 115522, Russia
GSK Investigational Site
Moscow, 119992, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2004
First Posted
October 7, 2004
Study Start
June 1, 2004
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
September 2, 2013
Record last verified: 2013-08