Back to resultsStudy of Escitalopram in Adult Patients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depressive Disorder, Escitalopram
Eligibility 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.
Sites / Locations
- Southwest Health, Ltd.
- Summit Research Network
- University of Nebraska Medical Center
- Summit Research Network
- CNS Research Institute
- Clinical Neuroscience Solutions
- Radiant Research
- Northwest Clinical Research Center
- Summit Research Network
Outcomes
Primary Outcome Measures
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary Outcome Measures
Hamilton Depression Rating Scale (HAMD)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00108979
Brief Title
Study of Escitalopram in Adult Patients With Major Depressive Disorder
Official Title
Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Forest Laboratories
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Major Depressive Disorder, Escitalopram
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAMD)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Southwest Health, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Summit Research Network
City
Okemos
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
CNS Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Radiant Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Summit Research Network
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21438794
Citation
Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28. Erratum In: Curr Med Res Opin. 2011 Sep;27(9):1708.
Results Reference
derived
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Study of Escitalopram in Adult Patients With Major Depressive Disorder
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