Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT01377194
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 568
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Levomilnacipran ER 40mg Levomilnacipran ER 2 Levomilnacipran ER 80mg of Levomilnacipran ER 3 Placebo Placebo
- Primary Outcome Measures
Name Time Method Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis. From Baseline to Week 8 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).
- Secondary Outcome Measures
Name Time Method Change in Sheehan Disability Scale (SDS) Total Score From Baseline to Week 8 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)
Trial Locations
- Locations (51)
Forest Investigative Site 011
🇺🇸Allentown, Pennsylvania, United States
Forest Investigative Site 044
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 023
🇺🇸Willingboro, New Jersey, United States
Forest Investigative Site 056
🇺🇸Prairie Village, Kansas, United States
Forest Investigative Site 043
🇺🇸Fort Myers, Florida, United States
Forest Investigative Site 018
🇺🇸Gainesville, Florida, United States
Forest Investigative Site 039
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 038
🇺🇸Newport Beach, California, United States
Forest Investigative Site 012
🇺🇸Encino, California, United States
Forest Investigative Site 001
🇺🇸Redlands, California, United States
Forest Investigative Site 037
🇺🇸Beverly Hills, California, United States
Forest Investigative Site 024
🇺🇸Oceanside, California, United States
Forest Investigative Site 021
🇺🇸Coral Springs, Florida, United States
Forest Investigative Site 050
🇺🇸Sherman Oaks, California, United States
Forest Investigative Site 031
🇺🇸San Diego, California, United States
Forest Investigative Site 034
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 060
🇺🇸Hallandale Beach, Florida, United States
Forest Investigative Site 020
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 005
🇺🇸Ocala, Florida, United States
Forest Investigative Site 014
🇺🇸Orlando, Florida, United States
Forest Investigative Site 041
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 028
🇺🇸Orlando, Florida, United States
Forest Investigative Site 026
🇺🇸Hoffman Estates, Illinois, United States
Forest Investigative Site 046
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 045
🇺🇸Indianapolis, Indiana, United States
Forest Investigative Site 049
🇺🇸Haverhill, Massachusetts, United States
Forest Investigative Site 051
🇺🇸New York, New York, United States
Forest Investigative Site 004
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 042
🇺🇸Orangeburg, New York, United States
Forest Investigative Site 002
🇺🇸Mount Kisco, New York, United States
Forest Investigative Site 061
🇺🇸Raleigh, North Carolina, United States
Forest Investigative Site 016
🇺🇸New York City, New York, United States
Forest Investigative Site 010
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 048
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 017
🇺🇸Salem, Oregon, United States
Forest Investigative Site 053
🇺🇸Portland, Oregon, United States
Forest Investigative Site 052
🇺🇸Bridgeville, Pennsylvania, United States
Forest Investigative Site 007
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 059
🇺🇸Lincoln, Rhode Island, United States
Forest Investigative Site 029
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 027
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 009
🇺🇸Dallas, Texas, United States
Forest Investigative Site 035
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 057
🇺🇸Spokane, Washington, United States
Forest Investigative Site 055
🇺🇸Seattle, Washington, United States
Forest Investigative Site 022
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 025
🇨🇦Kelowna, British Columbia, Canada
Forest Investigative Site 036
🇨🇦Sydney, Nova Scotia, Canada
Forest Investigative Site 006
🇨🇦Chatham, Ontario, Canada
Forest Investigative Site 003
🇨🇦Ottawa, Ontario, Canada
Forest Investigative Site 054
🇺🇸Chicago, Illinois, United States