Major Depressive Disorder Clinical Trial
Official title:
Fixed Dose Comparison of Escitalopram Combination 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 and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.
Status | Completed |
Enrollment | 540 |
Est. completion date | May 2006 |
Est. primary completion date | May 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 | Claghorn-Lesem Research Clinic | Bellaire | Texas |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Alpine Clinical Research | Boulder | Colorado |
United States | CNS Research Institute | Clementon | New Jersey |
United States | Radiant Research, Inc. | Denver | Colorado |
United States | Cunningham Clinical Research, LLC | Edwardsville | Illinois |
United States | Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee |
United States | Dominion Clinical Research | Midlothian | Virginia |
United States | Center for Emotional Fitness | Moorestown | New Jersey |
United States | Eastside Comprehensive Medical Center | New York | New York |
United States | Midwest Center for Neurobiological Medicine | Oakbrook Terrace | Illinois |
United States | Summit Research Network (Michigan), Inc. | Okemos | Michigan |
United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
United States | Southwest Health, Ltd | Phoenix | Arizona |
United States | Capital Clinical Research Associates | Rockville | Maryland |
United States | Croft Group Research Center | San Antonio | Texas |
United States | Summit Research Network (Seattle), LLC | Seattle | Washington |
United States | Piedmont Medical Research Associates, Inc. | Winston-Salem | North Carolina |
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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