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

Completed · Phase 4

Conditions studied: Major Depressive Disorder

In brief

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

Key facts

Study ID

NCT00384436

Run by

Forest Laboratories

People needed

580

Starts

2006-10-01

Last updated by the study team

2008-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet DSM-IV criteria for Major Depressive Disorder.
• Patients must have severe depression.
• MADRS greater than or equal to 30

You may not qualify if…

• 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.

Where it is running

• For information regarding investigative sites, contact Forest Professional Affairs — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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