Study of Escitalopram in Adult Patients With Major Depressive Disorder - Tabular View

Tracking Information
First Received Date ^ICMJE	April 21, 2005
Last Updated Date	December 18, 2007
Start Date ^ICMJE	March 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Montgomery Asberg Depression Rating Scale (MADRS)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00108979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Hamilton Depression Rating Scale (HAMD)
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Escitalopram in Adult Patients With Major Depressive Disorder
Official Title ^ICMJE	Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder
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, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Major Depressive Disorder
Intervention ^ICMJE	Drug: Escitalopram
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	240
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00108979
Responsible Party
Study ID Numbers ^ICMJE	SCT-MD-23
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Forest Laboratories
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP