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Clinical Trials/NCT00093288
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

GlaxoSmithKline1 site in 1 country364 target enrollmentJune 2004

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).

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
October 2005
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

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