- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108979
Study of Escitalopram in Adult Patients With Major Depressive Disorder
March 1, 2012 updated by: Forest Laboratories
Double-Blind Study of Escitalopram 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, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.
Study Overview
Study Type
Interventional
Enrollment
240
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
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Arizona
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Phoenix, Arizona, United States, 85016
- Southwest Health, Ltd.
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Michigan
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Okemos, Michigan, United States, 48864
- Summit Research Network
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Oregon
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Portland, Oregon, United States, 97210
- Summit Research Network
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19149
- CNS Research Institute
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Tennessee
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Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions
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Utah
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Salt Lake City, Utah, United States, 84107
- Radiant Research
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Washington
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Bellevue, Washington, United States, 98004
- Northwest Clinical Research Center
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Seattle, Washington, United States, 98104
- Summit Research Network
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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 |
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Montgomery Asberg Depression Rating Scale (MADRS)
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Secondary Outcome Measures
Outcome Measure |
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Hamilton Depression Rating Scale (HAMD)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
April 21, 2005
First Submitted That Met QC Criteria
April 21, 2005
First Posted (Estimate)
April 22, 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
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- SCT-MD-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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Clinical Trials on Escitalopram
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-
University of NebraskaRecruiting
-
Rigshospitalet, DenmarkUniversity of Cambridge; Lundbeck FoundationCompleted
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Ryerson UniversityUnknownInsomnia | Major Depressive DisorderCanada
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Centre Hospitalier Universitaire VaudoisNot yet recruitingPharmacogenetic Testing
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Shanghai 7th People's HospitalNot yet recruitingDepressive Disorder, MajorChina
-
Shanghai Mental Health CenterJiangsu Nhwa Pharmaceutical Co., Ltd.Completed
-
Shanghai Mental Health CenterRecruiting
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University of PennsylvaniaWashington University School of MedicineCompleted