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

Forest Laboratories1 site in 1 country580 target enrollmentOctober 2006

ConditionsMajor Depressive Disorder

Drugsescitalopram

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Forest Laboratories
Enrollment: 580
Locations: 1
Primary Endpoint: Time to premature discontinuation
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

October 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Forest Laboratories

Eligibility Criteria

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.