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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384436
• Other study ID #: SCT-MD-39
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2006
• Last updated: January 3, 2008
• Start date: October 2006

Study information

• Verified date: January 2008
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• escitalopram

Locations

Country	Name	City	State
United States	For information regarding investigative sites, contact Forest Professional Affairs	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to premature discontinuation
Secondary	Montgomery Asberg Depression Rating Scale (MADRS)