Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Levomilnacipran ER; Drug: Levomilnacipran ER; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 568
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Forest Investigative Site 025
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1S 2EB
      • Forest Investigative Site 036
  • Ontario
    • Chatham, Ontario, Canada, N7M 1B7
      • Forest Investigative Site 006
    • Ottawa, Ontario, Canada, K1G 4G3
      • Forest Investigative Site 003
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Forest Investigative Site 039
  • California
    • Beverly Hills, California, United States, 90210
      • Forest Investigative Site 037
    • Encino, California, United States, 91316
      • Forest Investigative Site 012
    • Newport Beach, California, United States, 92660
      • Forest Investigative Site 038
    • Oceanside, California, United States, 92056
      • Forest Investigative Site 024
    • Redlands, California, United States, 92374
      • Forest Investigative Site 001
    • San Diego, California, United States, 92108
      • Forest Investigative Site 031
    • Sherman Oaks, California, United States, 91403
      • Forest Investigative Site 050
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Forest Investigative Site 034
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Forest Investigative Site 021
    • Fort Myers, Florida, United States, 33912
      • Forest Investigative Site 043
    • Gainesville, Florida, United States, 32607
      • Forest Investigative Site 018
    • Hallandale Beach, Florida, United States, 33009
      • Forest Investigative Site 060
    • Jacksonville, Florida, United States, 32216
      • Forest Investigative Site 020
    • Ocala, Florida, United States, 34471
      • Forest Investigative Site 005
    • Orlando, Florida, United States, 32806
      • Forest Investigative Site 014
    • Orlando, Florida, United States, 32806
      • Forest Investigative Site 028
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Forest Investigative Site 046
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Forest Investigative Site 041
    • Chicago, Illinois, United States, 60640
      • Forest Investigative Site 054
    • Hoffman Estates, Illinois, United States, 60169
      • Forest Investigative Site 026
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Forest Investigative Site 045
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Forest Investigative Site 056
  • Massachusetts
    • Haverhill, Massachusetts, United States, 01830
      • Forest Investigative Site 049
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Forest Investigative Site 044
    • Willingboro, New Jersey, United States, 08046
      • Forest Investigative Site 023
  • New York
    • Brooklyn, New York, United States, 11214
      • Forest Investigative Site 004
    • Mount Kisco, New York, United States, 10549
      • Forest Investigative Site 002
    • New York, New York, United States, 10021
      • Forest Investigative Site 051
    • New York City, New York, United States, 10003
      • Forest Investigative Site 016
    • Orangeburg, New York, United States, 10962
      • Forest Investigative Site 042
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Forest Investigative Site 061
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Forest Investigative Site 010
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Forest Investigative Site 048
  • Oregon
    • Portland, Oregon, United States, 97210
      • Forest Investigative Site 053
    • Salem, Oregon, United States, 97301
      • Forest Investigative Site 017
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Forest Investigative Site 011
    • Bridgeville, Pennsylvania, United States, 15017
      • Forest Investigative Site 052
    • Philadelphia, Pennsylvania, United States, 19107
      • Forest Investigative Site 027
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Forest Investigative Site 059
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Forest Investigative Site 029
  • Texas
    • Dallas, Texas, United States, 75231
      • Forest Investigative Site 009
    • San Antonio, Texas, United States, 78229
      • Forest Investigative Site 007
    • San Antonio, Texas, United States, 78229
      • Forest Investigative Site 035
  • Washington
    • Bellevue, Washington, United States, 98007
      • Forest Investigative Site 022
    • Seattle, Washington, United States, 98104
      • Forest Investigative Site 055
    • Spokane, Washington, United States, 99204
      • Forest Investigative Site 057

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3; Placebo	Drug: Placebo; Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Experimental: 1; 40mg Levomilnacipran ER	Drug: Levomilnacipran ER; Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Drug: Levomilnacipran ER; Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Experimental: 2; 80mg of Levomilnacipran ER	Drug: Levomilnacipran ER; Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Drug: Levomilnacipran ER; Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Carl Gommoll, MS, Forest Research Institute, a subsidiary of Forest Laboratories

Publications and helpful links

General Publications

• Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
• Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (Estimate): June 21, 2011

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Depression; Major Depressive Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Milnacipran; Levomilnacipran
• Other Study ID Numbers: LVM-MD-10