Major Depressive Disorder Clinical Trial
Official title:
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
NCT number | NCT00384436 |
Other study ID # | SCT-MD-39 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | October 3, 2006 |
Last updated | January 3, 2008 |
Start date | October 2006 |
Verified date | January 2008 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients
Status | Completed |
Enrollment | 580 |
Est. completion date | |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients must meet DSM-IV criteria for Major Depressive Disorder. - Patients must have severe depression. - MADRS greater than or equal to 30 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 are considered a suicide risk. - Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia. - Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder. - Patients with history of any psychotic disorder or any psychotic feature. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | For information regarding investigative sites, contact Forest Professional Affairs | St Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to premature discontinuation | |||
Secondary | Montgomery Asberg Depression Rating Scale (MADRS) |
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