Study of Escitalopram in Adult Patients With Major Depressive Disorder
Information source: Forest Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Escitalopram (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Forest Laboratories
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, safety, and pharmacoeconomics of
escitalopram and an active comparator in patients with major depressive disorder.
Clinical Details
Official title: Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcome: Hamilton Depression Rating Scale (HAMD)
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Southwest Health, Ltd., Phoenix, Arizona 85016, United States
Summit Research Network, Okemos, Michigan 48864, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198, United States
Summit Research Network, Portland, Oregon 97210, United States
CNS Research Institute, Philadelphia, Pennsylvania 19149, United States
Clinical Neuroscience Solutions, Memphis, Tennessee 38119, United States
Radiant Research, Salt Lake City, Utah 84107, United States
Northwest Clinical Research Center, Bellevue, Washington 98004, United States
Summit Research Network, Seattle, Washington 98104, United States
Additional Information
Starting date: March 2005
Last updated: December 18, 2007
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