Major Depressive Disorder In The Elderly

Condition(s) targeted: Major Depressive Disorder

Intervention: bupropion XL (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).

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 design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Montgomery-Asberg Depression Rating Scale

Secondary outcome: Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale

Minimum age: 65 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Kelowna, British Columbia V1Y 2H5, Canada

GSK Clinical Trials Call Center, Oceanside, California 92056, United States

GSK Clinical Trials Call Center, Temecula, California 92591, United States

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Starting date: June 2004
Last updated: December 21, 2005