Escitalopram in Adult Patients With Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00668525

Run by

Forest Laboratories

People needed

877

Starts

2008-04-01

Last updated by the study team

2010-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Forest Investigative Site — Phoenix, Arizona, United States
• Forest Investigative Site — Arcadia, California, United States
• Forest Investigative Site — Encino, California, United States
• Forest Investigative Site — Garden Grove, California, United States
• Forest Investigative Site — Irvine, California, United States
• Forest Investigative Site — Los Alamitos, California, United States
• Forest Investigative Site — Denver, Colorado, United States
• Forest Investigative Site — Washington D.C., District of Columbia, United States
• Forest Investigative Site — Bradenton, Florida, United States
• Forest Investigative Site — Jacksonville, Florida, United States
• Forest Investigative Site — Orlando, Florida, United States
• Forest Investigative Site — West Palm Beach, Florida, United States
• Forest Investigative Site — Atlanta, Georgia, United States
• Forest Investigative Site — Newton, Kansas, United States
• Forest Investigative Site — Overland, Kansas, United States
• Forest Investigative Site — Baltimore, Maryland, United States
• Forest Investigative Site — Glen Burnie, Maryland, United States
• Forest Investigative Site — Rockville, Maryland, United States
• Forest Investigative Site — Okemos, Michigan, United States
• Forest Investigative Site — St Louis, Missouri, United States
• Forest Investigative Site — Omaha, Nebraska, United States
• Forest Investigative Site — Omaha, Nebraska, United States
• Forest Investigative Site — Cherry Hill, New Jersey, United States
• Forest Investigative Site — Clementon, New Jersey, United States
• Forest Investigative Site — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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