Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00109044
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Montgomery Asberg Depression Rating Scale (MADRS)
- Secondary Outcome Measures
Name Time Method Hamilton Depression Rating Scale (HAMD)
Trial Locations
- Locations (17)
Southwest Health, Ltd
🇺🇸Phoenix, Arizona, United States
Alpine Clinical Research
🇺🇸Boulder, Colorado, United States
Radiant Research, Inc.
🇺🇸Denver, Colorado, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Cunningham Clinical Research, LLC
🇺🇸Edwardsville, Illinois, United States
Midwest Center for Neurobiological Medicine
🇺🇸Oakbrook Terrace, Illinois, United States
Capital Clinical Research Associates
🇺🇸Rockville, Maryland, United States
Summit Research Network (Michigan), Inc.
🇺🇸Okemos, Michigan, United States
CNS Research Institute
🇺🇸Clementon, New Jersey, United States
Center for Emotional Fitness
🇺🇸Moorestown, New Jersey, United States
Scroll for more (7 remaining)Southwest Health, Ltd🇺🇸Phoenix, Arizona, United States