Depression Study In Elderly Patients
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
1 other identifier
interventional
560
1 country
46
Brief Summary
Major Depressive Disorder (MDD) Study in Elderly Outpatients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2003
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 19, 2003
CompletedFirst Posted
Study publicly available on registry
August 21, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedSeptember 1, 2016
August 1, 2016
1.6 years
August 19, 2003
August 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.
10 Weeks
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (46)
GSK Investigational Site
Little Rock, Arkansas, 72223, United States
GSK Investigational Site
Anaheim, California, 92805, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
El Centro, California, 92243, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Redlands, California, 92374, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Colorado Springs, Colorado, 80904, United States
GSK Investigational Site
Norwich, Connecticut, 06360, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Leesburg, Florida, 34748, United States
GSK Investigational Site
Miami, Florida, 33125, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Sebring, Florida, 33870, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Boise, Idaho, 83704, United States
GSK Investigational Site
Lafayette, Indiana, 47905, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Prairie Village, Kansas, 66206, United States
GSK Investigational Site
Gaithersburg, Maryland, 20877, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Braintree, Massachusetts, 02184, United States
GSK Investigational Site
Nashua, New Hampshire, 03060, United States
GSK Investigational Site
Clementon, New Jersey, 08021, United States
GSK Investigational Site
Princeton, New Jersey, 08540, United States
GSK Investigational Site
Mount Kisco, New York, 10549, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10024, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Greensboro, North Carolina, 27401, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73118, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Conshohocken, Pennsylvania, 19428, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19115, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Houston, Texas, 77007, United States
GSK Investigational Site
San Antonio, Texas, 78229-3815, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
Related 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 at: www.psych.org
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2003
First Posted
August 21, 2003
Study Start
June 1, 2003
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
September 1, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.