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

Forest Laboratories17 sites in 1 country540 target enrollmentMarch 2005

ConditionsMajor Depressive Disorder

DrugsEscitalopram

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Forest Laboratories
Enrollment: 540
Locations: 17
Primary Endpoint: Montgomery Asberg Depression Rating Scale (MADRS)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

May 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Forest Laboratories

Responsible Party

Sponsor

Eligibility 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.