Major Depressive Disorder Clinical Trial
Official title:
A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
Status | Completed |
Enrollment | 568 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Men and women, 18-75 years old - Currently meet the DSM-IV-TR criteria for Major Depressive Disorder - The patient's current depressive episode must be at least 6 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 who are considered a suicide risk - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Forest Investigative Site 006 | Chatham | Ontario |
Canada | Forest Investigative Site 025 | Kelowna | British Columbia |
Canada | Forest Investigative Site 003 | Ottawa | Ontario |
Canada | Forest Investigative Site 036 | Sydney | Nova Scotia |
United States | Forest Investigative Site 011 | Allentown | Pennsylvania |
United States | Forest Investigative Site 046 | Atlanta | Georgia |
United States | Forest Investigative Site 022 | Bellevue | Washington |
United States | Forest Investigative Site 037 | Beverly Hills | California |
United States | Forest Investigative Site 039 | Birmingham | Alabama |
United States | Forest Investigative Site 052 | Bridgeville | Pennsylvania |
United States | Forest Investigative Site 004 | Brooklyn | New York |
United States | Forest Investigative Site 044 | Cherry Hill | New Jersey |
United States | Forest Investigative Site 041 | Chicago | Illinois |
United States | Forest Investigative Site 054 | Chicago | Illinois |
United States | Forest Investigative Site 021 | Coral Springs | Florida |
United States | Forest Investigative Site 034 | Cromwell | Connecticut |
United States | Forest Investigative Site 009 | Dallas | Texas |
United States | Forest Investigative Site 010 | Dayton | Ohio |
United States | Forest Investigative Site 012 | Encino | California |
United States | Forest Investigative Site 043 | Fort Myers | Florida |
United States | Forest Investigative Site 018 | Gainesville | Florida |
United States | Forest Investigative Site 060 | Hallandale Beach | Florida |
United States | Forest Investigative Site 049 | Haverhill | Massachusetts |
United States | Forest Investigative Site 026 | Hoffman Estates | Illinois |
United States | Forest Investigative Site 045 | Indianapolis | Indiana |
United States | Forest Investigative Site 020 | Jacksonville | Florida |
United States | Forest Investigative Site 059 | Lincoln | Rhode Island |
United States | Forest Investigative Site 029 | Memphis | Tennessee |
United States | Forest Investigative Site 002 | Mount Kisco | New York |
United States | Forest Investigative Site 051 | New York | New York |
United States | Forest Investigative Site 016 | New York City | New York |
United States | Forest Investigative Site 038 | Newport Beach | California |
United States | Forest Investigative Site 005 | Ocala | Florida |
United States | Forest Investigative Site 024 | Oceanside | California |
United States | Forest Investigative Site 048 | Oklahoma City | Oklahoma |
United States | Forest Investigative Site 042 | Orangeburg | New York |
United States | Forest Investigative Site 014 | Orlando | Florida |
United States | Forest Investigative Site 028 | Orlando | Florida |
United States | Forest Investigative Site 027 | Philadelphia | Pennsylvania |
United States | Forest Investigative Site 053 | Portland | Oregon |
United States | Forest Investigative Site 056 | Prairie Village | Kansas |
United States | Forest Investigative Site 061 | Raleigh | North Carolina |
United States | Forest Investigative Site 001 | Redlands | California |
United States | Forest Investigative Site 017 | Salem | Oregon |
United States | Forest Investigative Site 007 | San Antonio | Texas |
United States | Forest Investigative Site 035 | San Antonio | Texas |
United States | Forest Investigative Site 031 | San Diego | California |
United States | Forest Investigative Site 055 | Seattle | Washington |
United States | Forest Investigative Site 050 | Sherman Oaks | California |
United States | Forest Investigative Site 057 | Spokane | Washington |
United States | Forest Investigative Site 023 | Willingboro | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis. | The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients 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 was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 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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