Depression Study In Elderly Patients

August 30, 2016 updated by: GlaxoSmithKline

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

Major Depressive Disorder (MDD) Study in Elderly Outpatients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • GSK Investigational Site
    • California
      • 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
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • GSK Investigational Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • GSK Investigational Site
    • Florida
      • 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
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • GSK Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • GSK Investigational Site
      • Prairie Village, Kansas, United States, 66206
        • GSK Investigational Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • GSK Investigational Site
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Massachusetts
      • Braintree, Massachusetts, United States, 02184
        • GSK Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • GSK Investigational Site
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • GSK Investigational Site
      • Princeton, New Jersey, United States, 08540
        • GSK Investigational Site
    • New York
      • 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
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27401
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
    • Pennsylvania
      • Conshohocken, Pennsylvania, United States, 19428
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19115
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Houston, Texas, United States, 77007
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229-3815
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
10 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

August 19, 2003

First Submitted That Met QC Criteria

August 20, 2003

First Posted (Estimate)

August 21, 2003

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29060/874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 29060/874
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 29060/874
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 29060/874
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 29060/874
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 29060/874
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: 29060/874
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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