Major Depressive Disorder Clinical Trial
Official title:
A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
NCT number | NCT00969150 |
Other study ID # | LVM-MD-02 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | August 31, 2009 |
Last updated | August 22, 2013 |
Start date | September 2009 |
Verified date | August 2013 |
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 efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder.
Status | Completed |
Enrollment | 362 |
Est. completion date | |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Men and women, 18-80 years old - Currently meet the DSM-IV-TR criteria for Major Depressive Disorder - The patient's current depressive episode must be at least 4 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: - any manic or hypomanic episode - schizophrenia or any other psychotic disorder - obsessive-compulsive disorder - Patients who are considered a suicide risk |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site | Bellevue | Washington |
United States | Forest Investigative Site | Brooklyn | New York |
United States | Forest Investigative Site 013 | Canton | Ohio |
United States | Forest Investigative Site | Cherry Hill | New Jersey |
United States | Forest Investigative Site | Chicago | Illinois |
United States | Forest Investigative Site | Dayton | Ohio |
United States | Forest Investigative Site | Denver | Colorado |
United States | Forest Investigative Site | Denver | Colorado |
United States | Forest Investigative Site | East Lansing | Michigan |
United States | Forest Investigative Site | Encino | California |
United States | Forest Investigative Site | Fall River | Massachusetts |
United States | Forest Investigative Site | Glen Burnie | Maryland |
United States | Forest Investigative Site | Jacksonville | Florida |
United States | Forest Investigative Site | Lincoln | Rhode Island |
United States | Forest Investigative Site | Los Alamitos | California |
United States | Forest Investigative Site | New York | New York |
United States | Forest Investigative Site | Oceanside | California |
United States | Forest Investigative Site | Orlando | Florida |
United States | Forest Investigative Site | Philadelphia | Pennsylvania |
United States | Forest Investigative Site | Portland | Oregon |
United States | Forest Investigative Site | Scottsdale | Arizona |
United States | Forest Investigative Site | Seattle | Washington |
United States | Forest Investigative Site | Staten Island | New York |
United States | Forest Investigative Site | Wichita | Kansas |
United States | Forest Investigative Site | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity). |
From Baseline to Week 8 | No |
Secondary | Change in Sheehan Disability Scale (SDS) Total Score | The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe) | From Baseline to Week 8 | No |
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