Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109044
• Other study ID #: SCT-MD-35
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2005
• Last updated: March 1, 2012
• Start date: March 2005
• Est. completion date: May 2006

Study information

• Verified date: March 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale (MADRS)
Secondary	Hamilton Depression Rating Scale (HAMD)