Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00109044

Run by

Forest Laboratories

People needed

540

Starts

2005-03-01

Expected to finish

2006-05-01

Last updated by the study team

2012-03-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southwest Health, Ltd — Phoenix, Arizona, United States
• Alpine Clinical Research — Boulder, Colorado, United States
• Radiant Research, Inc. — Denver, Colorado, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Cunningham Clinical Research, LLC — Edwardsville, Illinois, United States
• Midwest Center for Neurobiological Medicine — Oakbrook Terrace, Illinois, United States
• Capital Clinical Research Associates — Rockville, Maryland, United States
• Summit Research Network (Michigan), Inc. — Okemos, Michigan, United States
• CNS Research Institute — Clementon, New Jersey, United States
• Center for Emotional Fitness — Moorestown, New Jersey, United States
• Eastside Comprehensive Medical Center — New York, New York, United States
• Piedmont Medical Research Associates, Inc. — Winston-Salem, North Carolina, United States
• Clinical Neuroscience Solutions, Inc. — Memphis, Tennessee, United States
• Claghorn-Lesem Research Clinic — Bellaire, Texas, United States
• Croft Group Research Center — San Antonio, Texas, United States
• Dominion Clinical Research — Midlothian, Virginia, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Summit Research Network (Seattle), LLC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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