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

A Double-blind, Placebo-Controlled, Flexible-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 versus placebo in the treatment of outpatients with major depressive disorder

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 442
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Forest Investigative Site 055
  • Colorado
    • Highlands Ranch, Colorado, United States, 80130
      • Forest Investigative Site 065
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Forest Investigative Site 057
    • Boca Raton, Florida, United States, 33432
      • Forest Investigative Site 060
    • Gainesville, Florida, United States, 32607
      • Forest Investigative Site 064
    • Ocala, Florida, United States, 34471
      • Forest Investigative Site 053
    • Orlando, Florida, United States, 32806
      • Forest Investigative Site 061
    • Winter Park, Florida, United States, 32789
      • Forest Investigative Site 059
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Forest Investigative Site 070
    • Smyrna, Georgia, United States, 30080
      • Forest Investigative Site 066
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Forest Investigative Site 072
    • Oakbrook, Illinois, United States, 60523
      • Forest Investigative Site 050
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Forest Investigative Site 063
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Forest Investigative Site 071
  • Louisiana
    • Shreveport, Louisiana, United States, 71104
      • Forest Investigative Site 052
  • New York
    • Brooklyn, New York, United States, 11214
      • Forest Investigative Site 051
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Forest Investigative Site 056
    • Oklahoma City, Oklahoma, United States, 73112
      • Forest Investigative Site 067
  • Oregon
    • Salem, Oregon, United States, 97301
      • Forest Investigative Site 058
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Forest Investigative Site 054
  • Texas
    • San Antonio, Texas, United States, 78229
      • Forest Investigative Site 062
  • Virginia
    • Virginia Beach, Virginia, United States, 23452
      • Forest Investigative Site 068
  • Washington
    • Spokane, Washington, United States, 99204
      • Forest Investigative Site 069

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.	Drug: Levomilnacipran ER; Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Placebo Comparator: 2; Matching placebo capsules, oral administration, once daily dosing.	Drug: Placebo; Matching placebo 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	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

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 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.
• Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157.
• Sambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (Estimate): December 17, 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-03