Escitalopram in Adult Patients With Major Depressive Disorder

Condition(s) targeted: Major Depressive Disorder

Intervention: Escitalopram (Drug); Placebo (Drug); Escitalopram (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Carl Gommoll, MS, Study Director, Affiliation: Forest Laboratories

This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.

Official title: A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.

Secondary outcome: Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision

(DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.

- The patient's current depressive episode must be at least 8 weeks in duration.

Exclusion Criteria:

- Women who are pregnant, women who will be breastfeeding during the study, and women

with childbearing potential who are not practicing a reliable method of birth control.

- Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic

episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.

- Patients who are considered a suicide risk

- Patients with a history of seizures (including seizure disorder), stroke, significant

head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.

Forest Investigative Site, Phoenix, Arizona 85016, United States

Forest Investigative Site, Arcadia, California 91007, United States

Forest Investigative Site, Encino, California 91316, United States

Forest Investigative Site, Garden Grove, California 92845, United States

Forest Investigative Site, Irvine, California 92618, United States

Forest Investigative Site, Los Alamitos, California 90720, United States

Forest Investigative Site, Denver, Colorado 80212, United States

Forest Investigative Site, Washington, District of Columbia 20016, United States

Forest Investigative Site, Bradenton, Florida 34208, United States

Forest Investigative Site, Jacksonville, Florida 32216, United States

Forest Investigative Site, Orlando, Florida 32806, United States

Forest Investigative Site, West Palm Beach, Florida 33407, United States

Forest Investigative Site, Atlanta, Georgia 30328, United States

Forest Investigative Site, Newton, Kansas 67114, United States

Forest Investigative Site, Overland, Kansas 66221, United States

Forest Investigative Site, Baltimore, Maryland 21208, United States

Forest Investigative Site, Glen Burnie, Maryland 21061, United States

Forest Investigative Site, Rockville, Maryland 20852, United States

Forest Investigative Site, Okemos, Michigan 48864, United States

Forest Investigative Site, St. Louis, Missouri 63044, United States

Forest Investigative Site, Omaha, Nebraska 68131, United States

Forest Investigative Site, Omaha, Nebraska 68198, United States

Forest Investigative Site, Cherry Hill, New Jersey 08002, United States

Forest Investigative Site, Clementon, New Jersey 08021, United States

Forest Investigative Site, Bronx, New York 10467, United States

Forest Investigative Site, Brooklyn, New York 11235, United States

Forest Investigative Site, New York, New York 10021, United States

Forest Investigative Site, New York, New York 10024, United States

Forest Investigative Site, Staten Island, New York 10312, United States

Forest Investigative Site, Canton, Ohio 44708, United States

Forest Investigative Site, Dayton, Ohio 45408, United States

Forest Investigative Site, Portland, Oregon 97210, United States

Forest Investigative Site, Media, Pennsylvania 19063, United States

Forest Investigative Site, Philadelphia, Pennsylvania 19107, United States

Forest Investigative Site, Charleston, South Carolina 29405, United States

Forest Investigative Site, Memphis, Tennessee 38117, United States

Forest Investigative Site, Memphis, Tennessee 38119, United States

Forest Investigative Site, Austin, Texas 78756, United States

Forest Investigative Site, Houston, Texas 77008, United States

Forest Investigative Site, San Antonio, Texas 78229, United States

Forest Investigative Site, Salt Lake City, Utah 84107, United States

Forest Investigative Site, Woodstock, Vermont 05091, United States

Forest Investigative Site, Richmond, Virginia 23230, United States

Forest Investigative Site, Bellevue, Washington 98004, United States

Forest Investigative Site, Seattle, Washington 98104, United States

Starting date: April 2008
Last updated: May 7, 2010