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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

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

U.S. FDA Resources

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
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States, 77401
Croft Group Research Center
San Antonio, Texas, United States, 78229
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

No publications provided

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

Keywords provided by Forest Laboratories:

Depression
Major Depressive Disorder
Escitalopram

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012