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Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109044
Recruitment Status : Completed
First Posted : April 25, 2005
Last Update Posted : March 5, 2012
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Study Start Date : March 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAMD)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109044

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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

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Responsible Party: Forest Laboratories Identifier: NCT00109044     History of Changes
Other Study ID Numbers: SCT-MD-35
First Posted: April 25, 2005    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Keywords provided by Forest Laboratories:
Major Depressive Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents