Study of Escitalopram in Adult Patients With Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00108979
• Lead Sponsor: 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, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-04-21
• Study First Submitted QC: 2005-04-21
• Study First Posted: 2005-04-22
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD)

Trial Locations

Locations (7)

Clinical Neuroscience Solutions; 🇺🇸 Memphis, Tennessee, United States

Southwest Health, Ltd.; 🇺🇸 Phoenix, Arizona, United States

Summit Research Network; 🇺🇸 Seattle, Washington, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

CNS Research Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Radiant Research; 🇺🇸 Salt Lake City, Utah, United States