Major Depressive Disorder In The Elderly

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093288
• Other study ID #: AK130940
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2004
• Last updated: August 29, 2013
• Start date: June 2004
• Est. completion date: October 2005

Study information

• Verified date: August 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• bupropion XL

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Caboolture	Queensland
Australia	GSK Investigational Site	Everton Park	Queensland
Australia	GSK Investigational Site	New Farm	Queensland
Australia	GSK Investigational Site	St. Albans	Victoria
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Mont-Godinne
Belgium	GSK Investigational Site	Montignies-sur-Sambre
Finland	GSK Investigational Site	Mikkeli
Netherlands	GSK Investigational Site	Amersfoort
Netherlands	GSK Investigational Site	Grubbenvorst
Netherlands	GSK Investigational Site	Hilversum
Netherlands	GSK Investigational Site	Hoogvliet
Netherlands	GSK Investigational Site	Wildervank
Norway	GSK Investigational Site	Oslo
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Belgium,  Finland,  Netherlands,  Norway,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale
Secondary	Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale