Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Study Overview

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

Detailed Description

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

• Study Type: Interventional
• Enrollment (Actual): 734
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Forest Investigative Site #050
    • Vancouver, British Columbia, Canada, V6Z 2L4
      • Forest Investigative Site #051
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1S 2E8
      • Forest Investigative Site #052
  • Ontario
    • Chatham, Ontario, Canada, N7M 1B7
      • Forest Investigative Site #055
    • Ottawa, Ontario, Canada, K1G 4G3
      • Forest Investigative Site #053
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Forest Investigative Site #023
    • Encino, California, United States, 31316
      • Forest Investigative Site #017
    • Garden Grove, California, United States, 92845
      • Forest Investigative Site #021
    • Newport Beach, California, United States, 92660
      • Forest Investigative Site #025
    • Orange, California, United States, 92868
      • Forest Investigative Site #030
    • San Diego, California, United States, 92108
      • Forest Investigative Site #002
    • Sherman Oaks, California, United States, 91403
      • Forest Investigative Site #003
  • Florida
    • Bonita Springs, Florida, United States, 34134
      • Forest Research Institute #001
    • Fort Myers, Florida, United States, 33912
      • Forest Investigative Site #015
    • Maitland, Florida, United States, 32751
      • Forest Investigative Site #029
    • North Miami, Florida, United States, 33161
      • Forest Investigative Site #005
    • Orlando, Florida, United States, 32806
      • Forest Investigative Site #016
    • South Miami, Florida, United States, 33143
      • Forest Investigative Site #004
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Forest Investigative Site #014
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Forest Investigative Site #022
    • Chicago, Illinois, United States, 60640
      • Forest Investigative Site #006
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Forest Investigative Site #009
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Forest Investigative Site #013
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Forest Investigative Site #010
  • Missouri
    • Saint Louis, Missouri, United States, 63139
      • Forest Investigative Site #012
  • New York
    • Staten Island, New York, United States, 10312
      • Forest Investigative Site #011
  • Oregon
    • Portland, Oregon, United States, 97210
      • Forest Investigative Site #026
  • Pennsylvania
    • Bridgeville, Pennsylvania, United States, 15017
      • Forest Investigative Site #008
    • Norristown, Pennsylvania, United States, 19401
      • Forest Investigative Site #028
    • Philadelphia, Pennsylvania, United States, 19139
      • Forest Investigative Site #020
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Forest Investigative Site #024
  • Texas
    • Dallas, Texas, United States, 75231
      • Forest Investigative Site #007
    • San Antonio, Texas, United States, 78229
      • Forest Investigative Site #019
  • Washington
    • Bellevue, Washington, United States, 98007
      • Forest Investigative Site #018
    • Seattle, Washington, United States, 98104
      • Forest Investigative Site #027

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 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:

  • 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2; 40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.	Drug: Levomilnacipran ER; Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
Placebo Comparator: 1; Matching placebo capsules, oral administration, once daily dosing.	Drug: Placebo; Matching placebo to be given orally, in capsule form, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Relapse (Days)	Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4	24 Weeks

Collaborators and Investigators

• Sponsor: Forest Laboratories

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (Estimate): March 12, 2010

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; 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-05