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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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escitalopram

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No