Back to resultsMajor Depressive Disorder In The Elderly
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bupropion XL
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring MDD, bupropion, Depression
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00093288
Brief Title
Major Depressive Disorder In The Elderly
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
MDD, bupropion, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
364 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bupropion XL
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
GSK Investigational Site
City
Everton Park
State/Province
Queensland
ZIP/Postal Code
4053
Country
Australia
Facility Name
GSK Investigational Site
City
New Farm
State/Province
Queensland
ZIP/Postal Code
4005
Country
Australia
Facility Name
GSK Investigational Site
City
St. Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Mont-Godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
GSK Investigational Site
City
Montignies-sur-Sambre
ZIP/Postal Code
6061
Country
Belgium
Facility Name
GSK Investigational Site
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
GSK Investigational Site
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands
Facility Name
GSK Investigational Site
City
Grubbenvorst
ZIP/Postal Code
5971 BB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hilversum
ZIP/Postal Code
1211 PA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hoogvliet
ZIP/Postal Code
3192 JN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Wildervank
ZIP/Postal Code
9648 BE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Major Depressive Disorder In The Elderly
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