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

Phase 4

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00384436
• Lead Sponsor: Forest Laboratories

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-05
• Study First Posted: 2006-10-06
• Primary Completion: 2007-10
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-03
• Last Update Posted: 2008-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to premature discontinuation

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS)

Trial Locations

Locations (1)

For information regarding investigative sites, contact Forest Professional Affairs; 🇺🇸 St Louis, Missouri, United States