Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

March 1, 2012 updated by: Forest Laboratories

Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

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 efficacy and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

540

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Southwest Health, Ltd
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Alpine Clinical Research
      • Denver, Colorado, United States, 80212
        • Radiant Research, Inc.
    • Florida
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
    • Illinois
      • Edwardsville, Illinois, United States, 62025
        • Cunningham Clinical Research, Llc
      • Oakbrook Terrace, Illinois, United States, 60181
        • Midwest Center for Neurobiological Medicine
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Capital Clinical Research Associates
    • Michigan
      • Okemos, Michigan, United States, 48864
        • Summit Research Network (Michigan), Inc.
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • CNS Research Institute
      • Moorestown, New Jersey, United States, 08057
        • Center For Emotional Fitness
    • New York
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research Clinic
      • San Antonio, Texas, United States, 78229
        • Croft Group Research Center
    • Virginia
      • Midlothian, Virginia, United States, 23112-3989
        • Dominion Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle), LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
  • The patient's current depressive episode must be at least 12 weeks in duration.

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 currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
  • Patients who are considered a suicide risk.
  • Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Outcome Measure
Hamilton Depression Rating Scale (HAMD)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

April 22, 2005

First Submitted That Met QC Criteria

April 22, 2005

First Posted (Estimate)

April 25, 2005

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT-MD-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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