Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

Forest Laboratories580 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

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 safety and efficacy of escitalopram and an active comparator in severely depressed patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

580

Conditions

Major Depressive Disorder

Interventions

escitalopramDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must meet DSM-IV criteria for Major Depressive Disorder. * Patients must have severe depression. * MADRS greater than or equal to 30 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 are considered a suicide risk. * Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia. * Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder. * Patients with history of any psychotic disorder or any psychotic feature.

Locations (1)

For information regarding investigative sites, contact Forest Professional Affairs

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Time to premature discontinuation

Secondary Outcomes

Montgomery Asberg Depression Rating Scale (MADRS)

Data from ClinicalTrials.gov

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