Major Depressive Disorder Study In Adults

September 8, 2017 updated by: GlaxoSmithKline

An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability

A study to obtain safety and tolerability data

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

646

Phase

  • Phase 4

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
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Clinical Trial Call Center
      • Birmingham, Alabama, United States, 83704
        • GSK Clinical Trial Call Center
      • Fairfield, Alabama, United States, 35064
        • GSK Clinical Trial Call Center
      • Mobile, Alabama, United States, 36695
        • GSK Clinical Trial Call Center
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • GSK Clinical Trial Call Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72111
        • GSK Clinical Trial Call Center
      • Little Rock, Arkansas, United States, 72205
        • GSK Clinical Trial Call Center
    • California
      • Anaheim, California, United States, 92801
        • GSK Clinical Trial Call Center
      • Anaheim Hills, California, United States, 92807
        • GSK Clinical Trial Call Center
      • Bellflower, California, United States, 90706
        • GSK Clinical Trial Call Center
      • Cerritos, California, United States, 90703
        • GSK Clinical Trial Call Center
      • Clovis, California, United States, 93611
        • GSK Clinical Trial Call Center
      • Encino, California, United States, 91316
        • GSK Clinical Trial Call Center
      • Petaluma, California, United States, 94952
        • GSK Clinical Trial Call Center
      • Riverside, California, United States, 92506
        • GSK Clinical Trial Call Center
      • Sacramento, California, United States, 95823
        • GSK Clinical Trial Call Center
      • Sacramento, California, United States, 95825
        • GSK Clinical Trial Call Center
      • San Francisco, California, United States, 94109
        • GSK Clinical Trial Call Center
      • Temecula, California, United States, 92591
        • GSK Clinical Trial Call Center
      • Vista, California, United States, 92083
        • GSK Clinical Trial Call Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • GSK Clinical Trial Call Center
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • GSK Clinical Trial Call Center
      • Wilmington, Delaware, United States, 19810
        • GSK Clinical Trial Call Center
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • GSK Clinical Trial Call Center
      • Delray Beach, Florida, United States, 33484
        • GSK Clinical Trial Call Center
      • Fort Myers, Florida, United States, 33901
        • GSK Clinical Trial Call Center
      • Melbourne, Florida, United States, 32955
        • GSK Clinical Trial Call Center
      • Miami, Florida, United States, 33161
        • GSK Clinical Trial Call Center
      • Ocala, Florida, United States, 34474
        • GSK Clinical Trial Call Center
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • GSK Clinical Trial Call Center
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • GSK Clinical Trial Call Center
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • GSK Clinical Trial Call Center
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • GSK Clinical Trial Call Center
    • Louisiana
      • Lafayette, Louisiana, United States, 47905
        • GSK Clinical Trial Call Center
      • Lake Charles, Louisiana, United States, 70601
        • GSK Clinical Trial Call Center
      • New Orleans, Louisiana, United States, 70127
        • GSK Clinical Trial Call Center
    • Maryland
      • Prince Frederick, Maryland, United States, 20678
        • GSK Clinical Trial Call Center
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • GSK Clinical Trial Call Center
    • Missouri
      • Excelsior Springs, Missouri, United States, 64024
        • GSK Clinical Trial Call Center
      • Kansas City, Missouri, United States, 64132
        • GSK Clinical Trial Call Center
      • Saint Charles, Missouri, United States, 63301
        • GSK Clinical Trial Call Center
      • Saint Louis, Missouri, United States, 63128
        • GSK Clinical Trial Call Center
    • Nevada
      • Las Vegas, Nevada, United States, 89030
        • GSK Clinical Trial Call Center
      • Reno, Nevada, United States, 89501
        • GSK Clinical Trial Call Center
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • GSK Clinical Trial Call Center
      • Mercerville, New Jersey, United States, 08619
        • GSK Clinical Trial Call Center
      • Princeton, New Jersey, United States, 08540
        • GSK Clinical Trial Call Center
    • North Carolina
      • Carrboro, North Carolina, United States, 27510
        • GSK Clinical Trial Call Center
      • Cary, North Carolina, United States, 27511
        • GSK Clinical Trial Call Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • GSK Clinical Trial Call Center
      • Cincinnati, Ohio, United States, 45224
        • GSK Clinical Trial Call Center
      • Cleveland, Ohio, United States, 44106
        • GSK Clinical Trial Call Center
      • Independence, Ohio, United States, 44131
        • GSK Clinical Trial Call Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Clinical Trial Call Center
    • Oregon
      • Eugene, Oregon, United States, 97404
        • GSK Clinical Trial Call Center
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • GSK Clinical Trial Call Center
    • Tennessee
      • Bartlett, Tennessee, United States, 38134
        • GSK Clinical Trial Call Center
      • Cordova, Tennessee, United States, 38018
        • GSK Clinical Trial Call Center
      • Selmer, Tennessee, United States, 38375
        • GSK Clinical Trial Call Center
    • Texas
      • Conroe, Texas, United States, 77384
        • GSK Clinical Trial Call Center
      • Corsicana, Texas, United States, 75110
        • GSK Clinical Trial Call Center
      • Dallas, Texas, United States, 72505
        • GSK Clinical Trial Call Center
      • DeSoto, Texas, United States, 75115
        • GSK Clinical Trial Call Center
      • Fort Worth, Texas, United States, 76137
        • GSK Clinical Trial Call Center
      • Galveston, Texas, United States, 77555
        • GSK Clinical Trial Call Center
      • Richardson, Texas, United States, 75080
        • GSK Clinical Trial Call Center
      • Sugar Land, Texas, United States, 77478
        • GSK Clinical Trial Call Center
    • Utah
      • West Valley City, Utah, United States, 84120
        • GSK Clinical Trial Call Center
    • Virginia
      • Lebanon, Virginia, United States, 24266
        • GSK Clinical Trial Call Center
      • Richmond, Virginia, United States, 23230
        • GSK Clinical Trial Call Center
    • Washington
      • Kirkland, Washington, United States, 98034
        • GSK Clinical Trial Call Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must have primary diagnosis of Major Depressive Disorder (MDD).
  • Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
  • Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
  • Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.

Exclusion Criteria:

  • Patient has previously been treated with the study drug.
  • Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
  • Has a history of seizure disorder.
  • Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit.
  • Currently using an antidepressant.
  • Currently pregnant.

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: Non-Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events

Secondary Outcome Measures

Outcome Measure
Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Investigators

  • Study Chair: GSK Clinical Trials, MD, GlaxoSmithKline

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

September 1, 2002

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

November 18, 2002

First Submitted That Met QC Criteria

November 18, 2002

First Posted (Estimate)

November 19, 2002

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB29060.833

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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