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Depression Study In Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00067444
Recruitment Status : Completed
First Posted : August 21, 2003
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
Major Depressive Disorder (MDD) Study in Elderly Outpatients

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Major Depressive Disorder (MDD) Drug: Paroxetine CR Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005





Primary Outcome Measures :
  1. Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score. [ Time Frame: 10 Weeks ]

Secondary Outcome Measures :
  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. [ Time Frame: 10 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067444


Locations
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United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72223
United States, California
GSK Investigational Site
Anaheim, California, United States, 92805
GSK Investigational Site
Beverly Hills, California, United States, 90210
GSK Investigational Site
El Centro, California, United States, 92243
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Redlands, California, United States, 92374
GSK Investigational Site
Santa Ana, California, United States, 92705
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
United States, Connecticut
GSK Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Leesburg, Florida, United States, 34748
GSK Investigational Site
Miami, Florida, United States, 33125
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Sebring, Florida, United States, 33870
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83704
United States, Indiana
GSK Investigational Site
Lafayette, Indiana, United States, 47905
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
GSK Investigational Site
Prairie Village, Kansas, United States, 66206
United States, Maryland
GSK Investigational Site
Gaithersburg, Maryland, United States, 20877
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
GSK Investigational Site
Braintree, Massachusetts, United States, 02184
United States, New Hampshire
GSK Investigational Site
Nashua, New Hampshire, United States, 03060
United States, New Jersey
GSK Investigational Site
Clementon, New Jersey, United States, 08021
GSK Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
GSK Investigational Site
Mount Kisco, New York, United States, 10549
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
New York, New York, United States, 10024
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
GSK Investigational Site
Conshohocken, Pennsylvania, United States, 19428
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
United States, Rhode Island
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29407
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78756
GSK Investigational Site
Houston, Texas, United States, 77007
GSK Investigational Site
San Antonio, Texas, United States, 78229-3815
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 29060/874
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:
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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00067444    
Other Study ID Numbers: 29060/874
First Posted: August 21, 2003    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Elderly
Major Depressive Disorder
MDD
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors