NCT00093288CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 364
- Locations
- 16
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale
Study Overview
Brief Summary
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
Montgomery-Asberg Depression Rating Scale
Secondary Outcomes
- Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale
Investigators
Study Sites (16)
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