Major Depressive Disorder Clinical Trial
Official title:
Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder
Verified date | March 2012 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Clinical Neuroscience Solutions | Memphis | Tennessee |
United States | Summit Research Network | Okemos | Michigan |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | CNS Research Institute | Philadelphia | Pennsylvania |
United States | Southwest Health, Ltd. | Phoenix | Arizona |
United States | Summit Research Network | Portland | Oregon |
United States | Radiant Research | Salt Lake City | Utah |
United States | Summit Research Network | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery Asberg Depression Rating Scale (MADRS) | |||
Secondary | Hamilton Depression Rating Scale (HAMD) |
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