Major Depressive Disorder Clinical Trial
Official title:
A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder
NCT number | NCT00668525 |
Other study ID # | SCT-MD-49 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | April 28, 2008 |
Last updated | May 7, 2010 |
Start date | April 2008 |
Verified date | May 2010 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.
Status | Completed |
Enrollment | 877 |
Est. completion date | |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder. - The patient's current depressive episode must be at least 8 weeks in duration. Exclusion Criteria: - Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control. - Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder. - Patients who are considered a suicide risk - Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site | Arcadia | California |
United States | Forest Investigative Site | Atlanta | Georgia |
United States | Forest Investigative Site | Austin | Texas |
United States | Forest Investigative Site | Baltimore | Maryland |
United States | Forest Investigative Site | Bellevue | Washington |
United States | Forest Investigative Site | Bradenton | Florida |
United States | Forest Investigative Site | Bronx | New York |
United States | Forest Investigative Site | Brooklyn | New York |
United States | Forest Investigative Site | Canton | Ohio |
United States | Forest Investigative Site | Charleston | South Carolina |
United States | Forest Investigative Site | Cherry Hill | New Jersey |
United States | Forest Investigative Site | Clementon | New Jersey |
United States | Forest Investigative Site | Dayton | Ohio |
United States | Forest Investigative Site | Denver | Colorado |
United States | Forest Investigative Site | Encino | California |
United States | Forest Investigative Site | Garden Grove | California |
United States | Forest Investigative Site | Glen Burnie | Maryland |
United States | Forest Investigative Site | Houston | Texas |
United States | Forest Investigative Site | Irvine | California |
United States | Forest Investigative Site | Jacksonville | Florida |
United States | Forest Investigative Site | Los Alamitos | California |
United States | Forest Investigative Site | Media | Pennsylvania |
United States | Forest Investigative Site | Memphis | Tennessee |
United States | Forest Investigative Site | Memphis | Tennessee |
United States | Forest Investigative Site | New York | New York |
United States | Forest Investigative Site | New York | New York |
United States | Forest Investigative Site | Newton | Kansas |
United States | Forest Investigative Site | Okemos | Michigan |
United States | Forest Investigative Site | Omaha | Nebraska |
United States | Forest Investigative Site | Omaha | Nebraska |
United States | Forest Investigative Site | Orlando | Florida |
United States | Forest Investigative Site | Overland | Kansas |
United States | Forest Investigative Site | Philadelphia | Pennsylvania |
United States | Forest Investigative Site | Phoenix | Arizona |
United States | Forest Investigative Site | Portland | Oregon |
United States | Forest Investigative Site | Richmond | Virginia |
United States | Forest Investigative Site | Rockville | Maryland |
United States | Forest Investigative Site | Salt Lake City | Utah |
United States | Forest Investigative Site | San Antonio | Texas |
United States | Forest Investigative Site | Seattle | Washington |
United States | Forest Investigative Site | St. Louis | Missouri |
United States | Forest Investigative Site | Staten Island | New York |
United States | Forest Investigative Site | Washington | District of Columbia |
United States | Forest Investigative Site | West Palm Beach | Florida |
United States | Forest Investigative Site | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. | The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms). | Change from baseline in MADRS total score at week 8 | No |
Secondary | Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 | The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state). | Change from baseline in HAM-D at week 8 | No |
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