NCT00093288
Completed
Phase 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
ConditionsDepressive Disorder, Major
Drugsbupropion XL
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Depressive Disorder, Major
- Sponsor
- GlaxoSmithKline
- Enrollment
- 364
- Locations
- 1
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).
Investigators
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.
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
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive DisorderDepressive Disorder, MajorNCT00057213GlaxoSmithKline367
Completed
Phase 2
An 8 Week Study Of Adults Diagnosed With Major Depressive DisorderDepressive Disorder, MajorNCT00057226GlaxoSmithKline365
Completed
Phase 3
A Study To Evaluate PRX-00023 In Patients With Generalized Anxiety Disorder (GAD)Anxiety DisordersNCT00248183Epix Pharmaceuticals, Inc.310
Completed
Phase 3
Attention-Deficit Hyperactivity Disorder (ADHD) Study With AdultsAttention Deficit DisorderNCT00048360GlaxoSmithKline162
Completed
Phase 3
Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma ControlAsthmaNCT02281318GlaxoSmithKline556