Depressive Disorder, Major Clinical Trial
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
Verified date | August 2013 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
Status | Completed |
Enrollment | 364 |
Est. completion date | October 2005 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | GSK Investigational Site | Caboolture | Queensland |
Australia | GSK Investigational Site | Everton Park | Queensland |
Australia | GSK Investigational Site | New Farm | Queensland |
Australia | GSK Investigational Site | St. Albans | Victoria |
Belgium | GSK Investigational Site | Liège | |
Belgium | GSK Investigational Site | Mont-Godinne | |
Belgium | GSK Investigational Site | Montignies-sur-Sambre | |
Finland | GSK Investigational Site | Mikkeli | |
Netherlands | GSK Investigational Site | Amersfoort | |
Netherlands | GSK Investigational Site | Grubbenvorst | |
Netherlands | GSK Investigational Site | Hilversum | |
Netherlands | GSK Investigational Site | Hoogvliet | |
Netherlands | GSK Investigational Site | Wildervank | |
Norway | GSK Investigational Site | Oslo | |
Russian Federation | GSK Investigational Site | Moscow | |
Russian Federation | GSK Investigational Site | Moscow |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia, Belgium, Finland, Netherlands, Norway, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale | |||
Secondary | Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale |
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