Major Depressive Disorder In The Elderly

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00093288

Enrollment

364

Registered

2004-10-07

Start date

2004-06-30

Completion date

2005-10-31

Last updated

2013-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

MDD, bupropion, Depression

Brief summary

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

Interventions

DRUGbupropion XL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Montgomery-Asberg Depression Rating Scale	—

Secondary

Measure	Time frame
Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale	—

Countries

Australia, Belgium, Finland, Netherlands, Norway, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026