NCT Number: NCT00108979
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.
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Southwest Health, Ltd., Phoenix, Arizona, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcomes
-
Hamilton Depression Rating Scale (HAMD)
Sponsors and collaborators
Lead sponsor
Forest Laboratories
Industry
Registry information
Official study title
Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder
Important dates
- Study start
- 2005
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Apr 22, 2005
- Registry last updated
- Mar 5, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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