Depression Study In Elderly Patients

Phase 3

Completed

• Conditions: Depressive Disorder, Major; Major Depressive Disorder (MDD)

• Registration Number: NCT00067444
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Major Depressive Disorder (MDD) Study in Elderly Outpatients

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-08-19
• Study First Submitted QC: 2003-08-20
• Study First Posted: 2003-08-21
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• Diagnosis of Major Depressive Disorder (MDD).
• Current major depressive episode at screen at least 2 months duration.
• Must be at least 60 years of age.

Exclusion Criteria

• Patients with a primary diagnosis other than MDD.
• Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia.
• Patients with a history of brief depressive episodes lasting less than 8 weeks.
• Patients receiving formal psychotherapy within 12 weeks of study.
• Patients who are suicidal.
• Patients who have received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening.
• Patients with a history or seizure disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.	10 Weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in HAM-D item 1; Mean change from baseline in the CGI severity of illness score at study endpoint; Percentage of patients with HAM-D total score less than or equal to 7.	10 Weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Salt Lake City, Utah, United States