Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 724
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Forest Investigative Site
    • Scottsdale, Arizona, United States, 85254
      • Forest Investigative Site
  • California
    • Beverly Hills, California, United States, 90210
      • Forest Investigative Site
    • Costa Mesa, California, United States, 92626
      • Forest Investigative Site
    • Escondido, California, United States, 92025
      • Forest Investigative Site
    • Oceanside, California, United States, 92056
      • Forest Investigative Site
    • Sherman Oaks, California, United States, 91403
      • Forest Investigative Site
  • Colorado
    • Denver, Colorado, United States, 80239
      • Forest Investigative Site
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Forest Investigative Site
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Forest Investigative Site
    • Fort Myers, Florida, United States, 33912
      • Forest Investigative Site
    • Hallandale Beach, Florida, United States, 33009
      • Forest Investigative Site
    • Jacksonville, Florida, United States, 32216
      • Forest Investigative Site
    • Orlando, Florida, United States, 32806
      • Forest Investigative Site
    • West Palm Beach, Florida, United States, 33407
      • Forest Investigative Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Forest Investigative Site
  • Kansas
    • Wichita, Kansas, United States, 67206
      • Forest Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21285
      • Forest Investigative Site
    • Rockville, Maryland, United States, 20852
      • Forest Investigative Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Forest Investigative Site
    • Willingboro, New Jersey, United States, 08046
      • Forest Investigative Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Forest Investigative Site
    • Mt. Kisco, New York, United States, 10549
      • Forest Investigative Site
    • New York, New York, United States, 10003
      • Forest Investigative Site
    • New York, New York, United States, 10021
      • Forest Investigative Site
    • Staten Island, New York, United States, 10312
      • Forest Investigative Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Forest Investigative Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Forest Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Forest Investigative Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Forest Investigative Site
    • Norristown, Pennsylvania, United States, 19403
      • Forest Investigative Site
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Forest Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Forest Investigative Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Forest Investigative Site
    • Dallas, Texas, United States, 75231
      • Forest Investigative Site
    • San Antonio, Texas, United States, 78229
      • Forest Investigative Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Forest Investigative Site
    • Seattle, Washington, United States, 98104
      • Forest Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women, 18-65 years old
• Currently meet the DSM-IV-TR 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:

  • any manic or hypomanic episode
  • schizophrenia or any other psychotic disorder
  • obsessive-compulsive disorder
• Patients who are considered a suicide risk

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.	Drug: Levomilnacipran ER; Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.; Drug: Levomilnacipran ER; Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.; Drug: Levomilnacipran ER; Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
Experimental: 2; 80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing	Drug: Levomilnacipran ER; Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.; Drug: Levomilnacipran ER; Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.; Drug: Levomilnacipran ER; Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
Experimental: 3; 120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing	Drug: Levomilnacipran ER; Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.; Drug: Levomilnacipran ER; Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.; Drug: Levomilnacipran ER; Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
Placebo Comparator: 4; Matching placebo capsules, oral administration, once daily.	Drug: Placebo; Matching placebo capsules, oral administration, once daily for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	The 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 for all measured symptoms).	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 functional 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 for all measured symptoms)	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 Inc.

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.
• Blum SI, Tourkodimitris S, Ruth A. Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder. J Affect Disord. 2015 Jan 1;170:230-6. doi: 10.1016/j.jad.2014.09.005. Epub 2014 Sep 10.
• Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Mar;74(3):242-8. doi: 10.4088/JCP.12m08197.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 31, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (Estimate): September 1, 2009

Study Record Updates

• Last Update Posted (Estimate): October 25, 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-01