Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder - Full Text View

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00109044

Purpose

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Escitalopram	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures:

Hamilton Depression Rating Scale (HAMD)

Estimated Enrollment:	540
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
Patients who are considered a suicide risk.
Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109044

Locations

United States, Arizona
Southwest Health, Ltd
Phoenix, Arizona, United States, 85016
United States, Colorado
Alpine Clinical Research
Boulder, Colorado, United States, 80304
Radiant Research, Inc.
Denver, Colorado, United States, 80212
United States, Florida
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
United States, Illinois
Cunningham Clinical Research, LLC
Edwardsville, Illinois, United States, 62025
Midwest Center for Neurobiological Medicine
Oakbrook Terrace, Illinois, United States, 60181
United States, Maryland
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852
United States, Michigan
Summit Research Network (Michigan), Inc.
Okemos, Michigan, United States, 48864
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 08021
Center for Emotional Fitness
Moorestown, New Jersey, United States, 08057
United States, New York
Eastside Comprehensive Medical Center
New York, New York, United States, 10021
United States, North Carolina
Piedmont Medical Research Associates, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Croft Group Research Center
San Antonio, Texas, United States, 78229
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States, 77401
United States, Virginia
Dominion Clinical Research
Midlothian, Virginia, United States, 23112-3989
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Summit Research Network (Seattle), LLC
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Forest Laboratories

More Information

Study ID Numbers:	SCT-MD-35
Study First Received:	April 22, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00109044
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Depression
Major Depressive Disorder
Escitalopram

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Dexetimide

Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009