A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00048204

Purpose

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Condition	Intervention	Phase
Major Depressive Disorder	Drug: GW597599B Drug: paroxetine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Hamilton Depression Rating Scale [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:

Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale [ Time Frame: 8 Weeks ]

Enrollment:	372
Study Start Date:	November 2002

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients meet the diagnosis of Major Depressive Disorder (MDD).

Exclusion Criteria:

Patients with a primary diagnosis other than MDD.
Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
Patient is actively suicidal.
Patients who have a history of migraine headaches.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048204

Hide Study Locations

Locations

United States, California
GSK Clinical Trial Call Center
Irvine, California, United States, 92618
GSK Clinical Trial Call Center\
Beverly Hills, California, United States, 90210
GSK Clinical Trial Call Center
San Marcos, California, United States, 92078
GSK Clinical Trial Call Center
El Centro, California, United States, 92243
GSK Clinical Trial Call Center
Garden Grove, California, United States, 92845
GSK Clinical Trial Call Center
Santa Ana, California, United States, 62701
GSK Clinical Trial Call Center
Stanford, California, United States, 94305
United States, Colorado
GSK Clinical Trial Call Center
Denver, Colorado, United States, 80212
United States, Connecticut
GSK Clinical Trial Call Center
Farmington, Connecticut, United States, 06030
United States, Florida
GSK Clinical Trial Call Center
Jacksonville, Florida, United States, 32257
GSK Clinical Trial Call Center
Jacksonville, Florida, United States, 32216
United States, Georgia
GSK Clinical Trial Call Center
Atlanta, Georgia, United States, 30329
GSK Clinical Trial Call Center
Atlanta, Georgia, United States, 30308
GSK Clinical Trial Call Center
Marietta, Georgia, United States, 30060
United States, Illinois
GSK Clinical Trial Call Center
Libertyville, Illinois, United States, 60084
United States, Kentucky
GSK Clinical Trial Call Center
Lexington, Kentucky, United States, 40509
United States, Maryland
GSK Clinical Trial Call Center
Glen Burnie, Maryland, United States, 21061
United States, Michigan
GSK Clinical Trial Call Center
New Baltimore, Michigan, United States, 48047
GSK Clinical Trial Call Center
Okemos, Michigan, United States, 48864
United States, Nevada
GSK Clinical Trial Call Center
Las Vegas, Nevada, United States, 89146
United States, New Jersey
GSK Clinical Trial Call Center
Kenilworth, New Jersey, United States, 07033
GSK Clinical Trial Call Center\
Clementon, New Jersey, United States, 08021
United States, New York
GSK Clinical Trial Call Center
New York, New York, United States, 10024
GSK Clinical Trial Call Center
New York, New York, United States, 10021
GSK Clinical Trial Call Center
New York, New York, United States, 10467
United States, North Carolina
GSK Clinical Trial Call Center
Durham, North Carolina, United States, 27710
United States, Oregon
GSK Clinical Trial Call Center
Eugene, Oregon, United States, 97401
GSK Clinical Trial Call Center
Salem, Oregon, United States, 97309
United States, Tennessee
GSK Clinical Trial Call Center
Nashville, Tennessee, United States, 37212
United States, Texas
GSK Clinical Trial Call Center
Austin, Texas, United States, 78756
GSK Clinical Trial Call Center
San Antonio, Texas, United States, 78229
GSK Clinical Trial Call Center
Houston, Texas, United States, 77007
GSK Clinical Trial Call Center
Bellaire, Texas, United States, 97305
GSK Clinical Trial Call Center
Lake Jackson, Texas, United States, 77566
United States, Virginia
GSK Clinical Trial Call Center
Richmond, Virginia, United States, 23294
Canada
GSK Clinical Trial Call Center
Quebec, Canada, G1R 2W8
Canada, Alberta
GSK Clinical Trial Call Center
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
GSK Clinical Trial Call Center
Kelowna, British Columbia, Canada, V1Y2H4
Canada, Manitoba
GSK Clinical Trial Call Center
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
GSK Clinical Trial Call Center
Miramichi, New Brunswick, Canada, E1V 3G5
Canada, Nova Scotia
GSK Clinical Trial Call Center
Sydney, Nova Scotia, Canada, B1S2E9
Canada, Ontario
GSK Clinical Trial Call Center
Toronto, Ontario, Canada, M5G 2C4
GSK Clinical Trial Call Center
Markham, Ontario, Canada, L6B 1A1
GSK Clinical Trial Call Center
Toronto, Ontario, Canada, M5T3A9
Canada, Quebec
GSK Clinical Trial Call Center
Sherbrooke, Quebec, Canada, J1H 4J6

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, MD, MPH

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	NKD20006
Study First Received:	October 28, 2002
Last Updated:	August 8, 2007
ClinicalTrials.gov Identifier:	NCT00048204 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Major Depressive Disorder
Depression
Psychiatry

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