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Major Depressive Disorder Study In Adults
This study has been completed.
First Received: November 18, 2002   Last Updated: January 15, 2008   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00049972
  Purpose

A study to obtain safety and tolerability data


Condition Intervention Phase
Major Depressive Disorder
 Drug: paroxetine CR
 Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Depression
Drug Information available for: Serotonin Paroxetine Paroxetine hydrochloride Paroxetine Mesylate
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 646
Study Start Date: September 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049972

  Hide Study Locations
Locations
United States, Alabama
GSK Clinical Trial Call Center
BIRMINGHAM, Alabama, United States, 83704
GSK Clinical Trial Call Center
BIRMINGHAM, Alabama, United States, 35209
GSK Clinical Trial Call Center
MOBILE, Alabama, United States, 36695
GSK Clinical Trial Call Center
FAIRFIELD, Alabama, United States, 35064
United States, Arizona
GSK Clinical Trial Call Center
Phoenix, Arizona, United States, 85015
United States, Arkansas
GSK Clinical Trial Call Center
LITTLE ROCK, Arkansas, United States, 72111
GSK Clinical Trial Call Center
LITTLE ROCK, Arkansas, United States, 72205
United States, California
GSK Clinical Trial Call Center
CERRITOS, California, United States, 90703
GSK Clinical Trial Call Center
SACRAMENTO, California, United States, 95823
GSK Clinical Trial Call Center
TEMECULA, California, United States, 92591
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
VISTA, California, United States, 92083
GSK Clinical Trial Call Center
SAN FRANCISCO, California, United States, 94109
GSK Clinical Trial Call Center\
ANAHEIM HILLS, California, United States, 92807
GSK Clinical Trial Call Center
CLOVIS, California, United States, 93611
GSK Clinical Trial Call Center
ANAHEIM, California, United States, 92801
GSK Clinical Trial Call Center
SACRAMENTO, California, United States, 95825
GSK Clinical Trial Call Center
BELLFLOWER, California, United States, 90706
GSK Clinical Trial Call Center
RIVERSIDE, California, United States, 92506
United States, Colorado
GSK Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80904
United States, Delaware
GSK Clinical Trial Call Center
WILMINGTON, Delaware, United States, 19810
GSK Clinical Trial Call Center
WILMINGTON, Delaware, United States, 19803
United States, Florida
GSK Clinical Trial Call Center
MIAMI, Florida, United States, 33161
GSK Clinical Trial Call Center
MIAMI, Florida, United States, 33161
GSK Clinical Trial Call Center
DELRAY BEACH, Florida, United States, 33484
GSK Clinical Trial Call Center
OCALA, Florida, United States, 34474
GSK Clinical Trial Call Center
Melbourne, Florida, United States, 32955
GSK Clinical Trial Call Center
Boynton Beach, Florida, United States, 33426
GSK Clinical Trial Call Center\
Fort Myers, Florida, United States, 33901
United States, Georgia
GSK Clinical Trial Call Center
ATLANTA, Georgia, United States, 30312
United States, Idaho
GSK Clinical Trial Call Center
IDAHO FALLS, Idaho, United States, 83404
United States, Illinois
GSK Clinical Trial Call Center
GURNEE, Illinois, United States, 60031
United States, Indiana
GSK Clinical Trial Call Center
Greenwood, Indiana, United States, 46143
United States, Louisiana
GSK Clinical Trial Call Center
NEW ORLEANS, Louisiana, United States, 70127
GSK Clinical Trial Call Center
LAFAYETTE, Louisiana, United States, 47905
GSK Clinical Trial Call Center\
Lake Charles, Louisiana, United States, 70601
United States, Maryland
GSK Clinical Trial Call Center
PRINCE FREDERICK, Maryland, United States, 20678
United States, Massachusetts
GSK Clinical Trial Call Center
SPRINGFIELD, Massachusetts, United States, 01107
United States, Missouri
GSK Clinical Trial Call Center
St Louis, Missouri, United States, 63128
GSK Clinical Trial Call Center
EXCELSIOR SPRINGS, Missouri, United States, 64024
GSK Clinical Trial Call Center
St. Charles, Missouri, United States, 63301
GSK Clinical Trial Call Center\
KANSAS CITY, Missouri, United States, 64132
United States, Nevada
GSK Clinical Trial Call Center
RENO, Nevada, United States, 89501
GSK Clinical Trial Call Center
LAS VEGAS, Nevada, United States, 89030
United States, New Jersey
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
BLACKWOOD, New Jersey, United States, 08012
United States, North Carolina
GSK Clinical Trial Call Center
CARRBORO, North Carolina, United States, 27510
GSK Clinical Trial Call Center
Cary, North Carolina, United States, 27511
United States, Ohio
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
CINCINNATI, Ohio, United States, 45219
United States, Oklahoma
GSK Clinical Trial Call Center
OKLAHOMA CITY, Oklahoma, United States, 73112
United States, Oregon
GSK Clinical Trial Call Center
Eugene, Oregon, United States, 97404
United States, Pennsylvania
GSK Clinical Trial Call Center
Downingtown, Pennsylvania, United States, 19335
United States, Tennessee
GSK Clinical Trial Call Center
BARTLETT, Tennessee, United States, 38134
GSK Clinical Trial Call Center
SELMER, Tennessee, United States, 38375
GSK Clinical Trial Call Center
CORDOVA, Tennessee, United States, 38018
United States, Texas
GSK Clinical Trial Call Center
CONROE, Texas, United States, 77384
GSK Clinical Trial Call Center
SUGAR LAND, Texas, United States, 77478
GSK Clinical Trial Call Center
CORSICANA, Texas, United States, 75110
GSK Clinical Trial Call Center\
Fort Worth, Texas, United States, 76137
GSK Clinical Trial Call Center
RICHARDSON, Texas, United States, 75080
GSK Clinical Trial Call Center\
DALLAS, Texas, United States, 72505
GSK Clinical Trial Call Center
GALVESTON, Texas, United States, 77555
GSK Clinical Trial Call Center
DESOTO, Texas, United States, 75115
United States, Utah
GSK Clinical Trial Call Center
WEST VALLEY CITY, Utah, United States, 84120
United States, Virginia
GSK Clinical Trial Call Center
Lebanon, Virginia, United States, 24266
GSK Clinical Trial Call Center
RICHMOND, Virginia, United States, 23230
United States, Washington
GSK Clinical Trial Call Center\
KIRKLAND, Washington, United States, 98034
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Chair: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Study ID Numbers: SB29060.833
Study First Received: November 18, 2002
Last Updated: January 15, 2008
ClinicalTrials.gov Identifier: NCT00049972     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Major Depressive Disorder Open-label discontinued

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin Uptake Inhibitors
 Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009



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