Depression Study In Elderly Patients

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Evaluating the Efficacy and Safety of Paroxetine CR in Elderly Outpatients Diagnosed With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067444
• Other study ID #: 29060/874
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2003
• Last updated: August 30, 2016
• Start date: June 2003
• Est. completion date: January 2005

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Major Depressive Disorder (MDD) Study in Elderly Outpatients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

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
• Disease
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Paroxetine CR

Locations

Country	Name	City	State
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Braintree	Massachusetts
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Clementon	New Jersey
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Conshohocken	Pennsylvania
United States	GSK Investigational Site	East Providence	Rhode Island
United States	GSK Investigational Site	El Centro	California
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Gaithersburg	Maryland
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lafayette	Indiana
United States	GSK Investigational Site	Leesburg	Florida
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Mount Kisco	New York
United States	GSK Investigational Site	Nashua	New Hampshire
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Norwich	Connecticut
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Prairie Village	Kansas
United States	GSK Investigational Site	Princeton	New Jersey
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Redlands	California
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Santa Ana	California
United States	GSK Investigational Site	Sebring	Florida
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pitts CD, Schaefer D, Lipschitz A, Iyengar M: Efficacy and Tolerability of Fixed, Low Dose Paroxetine CR in the Treatment of Depression in the Elderly, Poster No. NR701, presented at the American Psychiatric Association Annual Meeting, May 2005. Available

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.		10 Weeks	No
Secondary	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	No

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.