Major Depressive Disorder Study In Adults

NCT ID: NCT00049972

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-09-30

Brief Summary

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A study to obtain safety and tolerability data

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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paroxetine CR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_CHAIR

GlaxoSmithKline

Locations

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GSK Clinical Trial Call Center

Birmingham, Alabama, United States

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GSK Clinical Trial Call Center

Birmingham, Alabama, United States

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GSK Clinical Trial Call Center

Fairfield, Alabama, United States

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GSK Clinical Trial Call Center

Mobile, Alabama, United States

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GSK Clinical Trial Call Center

Phoenix, Arizona, United States

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GSK Clinical Trial Call Center

Little Rock, Arkansas, United States

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GSK Clinical Trial Call Center

Little Rock, Arkansas, United States

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GSK Clinical Trial Call Center

Anaheim, California, United States

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GSK Clinical Trial Call Center

Anaheim Hills, California, United States

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GSK Clinical Trial Call Center

Bellflower, California, United States

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GSK Clinical Trial Call Center

Cerritos, California, United States

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GSK Clinical Trial Call Center

Clovis, California, United States

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GSK Clinical Trial Call Center

Encino, California, United States

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GSK Clinical Trial Call Center

Petaluma, California, United States

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GSK Clinical Trial Call Center

Riverside, California, United States

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GSK Clinical Trial Call Center

Sacramento, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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GSK Clinical Trial Call Center

Temecula, California, United States

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GSK Clinical Trial Call Center

Vista, California, United States

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GSK Clinical Trial Call Center

Colorado Springs, Colorado, United States

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GSK Clinical Trial Call Center

Wilmington, Delaware, United States

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Wilmington, Delaware, United States

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GSK Clinical Trial Call Center

Boynton Beach, Florida, United States

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GSK Clinical Trial Call Center

Delray Beach, Florida, United States

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GSK Clinical Trial Call Center

Fort Myers, Florida, United States

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GSK Clinical Trial Call Center

Melbourne, Florida, United States

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GSK Clinical Trial Call Center

Miami, Florida, United States

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Ocala, Florida, United States

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GSK Clinical Trial Call Center

Atlanta, Georgia, United States

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GSK Clinical Trial Call Center

Idaho Falls, Idaho, United States

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GSK Clinical Trial Call Center

Gurnee, Illinois, United States

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Greenwood, Indiana, United States

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Lafayette, Louisiana, United States

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GSK Clinical Trial Call Center

Lake Charles, Louisiana, United States

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GSK Clinical Trial Call Center

New Orleans, Louisiana, United States

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Prince Frederick, Maryland, United States

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Springfield, Massachusetts, United States

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GSK Clinical Trial Call Center

Excelsior Springs, Missouri, United States

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GSK Clinical Trial Call Center

Kansas City, Missouri, United States

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GSK Clinical Trial Call Center

Saint Charles, Missouri, United States

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GSK Clinical Trial Call Center

St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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GSK Clinical Trial Call Center

Blackwood, New Jersey, United States

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Mercerville, New Jersey, United States

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Princeton, New Jersey, United States

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GSK Clinical Trial Call Center

Carrboro, North Carolina, United States

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GSK Clinical Trial Call Center

Cary, North Carolina, United States

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GSK Clinical Trial Call Center

Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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GSK Clinical Trial Call Center

Cleveland, Ohio, United States

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GSK Clinical Trial Call Center

Independence, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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GSK Clinical Trial Call Center

Downingtown, Pennsylvania, United States

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GSK Clinical Trial Call Center

Bartlett, Tennessee, United States

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GSK Clinical Trial Call Center

Cordova, Tennessee, United States

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GSK Clinical Trial Call Center

Selmer, Tennessee, United States

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GSK Clinical Trial Call Center

Conroe, Texas, United States

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GSK Clinical Trial Call Center

Corsicana, Texas, United States

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GSK Clinical Trial Call Center

Dallas, Texas, United States

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GSK Clinical Trial Call Center

DeSoto, Texas, United States

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GSK Clinical Trial Call Center

Fort Worth, Texas, United States

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GSK Clinical Trial Call Center

Galveston, Texas, United States

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GSK Clinical Trial Call Center

Richardson, Texas, United States

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GSK Clinical Trial Call Center

Sugar Land, Texas, United States

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GSK Clinical Trial Call Center

West Valley City, Utah, United States

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GSK Clinical Trial Call Center

Lebanon, Virginia, United States

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GSK Clinical Trial Call Center

Richmond, Virginia, United States

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GSK Clinical Trial Call Center

Kirkland, Washington, United States

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Countries

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United States

Other Identifiers

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SB29060.833

Identifier Type: -

Identifier Source: org_study_id

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