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Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Information source: Forest Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Escitalopram (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

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.

Clinical Details

Official title: Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Montgomery Asberg Depression Rating Scale (MADRS)

Secondary outcome: Hamilton Depression Rating Scale (HAMD)

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Southwest Health, Ltd, Phoenix, Arizona 85016, United States

Alpine Clinical Research, Boulder, Colorado 80304, United States

Radiant Research, Inc., Denver, Colorado 80212, United States

Clinical Neuroscience Solutions, Inc., Orlando, Florida 32806, United States

Cunningham Clinical Research, LLC, Edwardsville, Illinois 62025, United States

Midwest Center for Neurobiological Medicine, Oakbrook Terrace, Illinois 60181, United States

Capital Clinical Research Associates, Rockville, Maryland 20852, United States

Summit Research Network (Michigan), Inc., Okemos, Michigan 48864, United States

CNS Research Institute, Clementon, New Jersey 08021, United States

Center for Emotional Fitness, Moorestown, New Jersey 08057, United States

Eastside Comprehensive Medical Center, New York, New York 10021, United States

Piedmont Medical Research Associates, Inc., Winston-Salem, North Carolina 27103, United States

Clinical Neuroscience Solutions, Inc., Memphis, Tennessee 38119, United States

Croft Group Research Center, San Antonio, Texas 78229, United States

Claghorn-Lesem Research Clinic, Bellaire, Texas 77401, United States

Dominion Clinical Research, Midlothian, Virginia 23112-3989, United States

Northwest Clinical Research Center, Bellevue, Washington 98004, United States

Summit Research Network (Seattle), LLC, Seattle, Washington 98104, United States

Additional Information

Starting date: March 2005
Last updated: December 18, 2007

Page last updated: June 20, 2008

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