Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

NCT ID: NCT00109044

Last Updated: 2012-03-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Escitalopram

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Southwest Health, Ltd

Phoenix, Arizona, United States

Site Status

Alpine Clinical Research

Boulder, Colorado, United States

Site Status

Radiant Research, Inc.

Denver, Colorado, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Cunningham Clinical Research, LLC

Edwardsville, Illinois, United States

Site Status

Midwest Center for Neurobiological Medicine

Oakbrook Terrace, Illinois, United States

Site Status

Capital Clinical Research Associates

Rockville, Maryland, United States

Site Status

Summit Research Network (Michigan), Inc.

Okemos, Michigan, United States

Site Status

CNS Research Institute

Clementon, New Jersey, United States

Site Status

Center for Emotional Fitness

Moorestown, New Jersey, United States

Site Status

Eastside Comprehensive Medical Center

New York, New York, United States

Site Status

Piedmont Medical Research Associates, Inc.

Winston-Salem, North Carolina, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Site Status

Claghorn-Lesem Research Clinic

Bellaire, Texas, United States

Site Status

Croft Group Research Center

San Antonio, Texas, United States

Site Status

Dominion Clinical Research

Midlothian, Virginia, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Summit Research Network (Seattle), LLC

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCT-MD-35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pattern Separation in Major Depressive Disorder
NCT07139834 NOT_YET_RECRUITING PHASE1
Neurotrophic Factors and Depression
NCT00812994 COMPLETED PHASE4