A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder

September 28, 2018 updated by: Forest Laboratories

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

This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

644

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Forest Investigative Site 053
      • Dothan, Alabama, United States, 36303
        • Forest Investigative Site 050
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Forest Investigative Site 039
    • California
      • Beverly Hills, California, United States, 90210
        • Forest Investigative Site 048
      • Chino, California, United States, 91710
        • Forest Investigative Site 047
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 028
      • Encino, California, United States, 91316
        • Forest Investigative Site 021
      • Lemon Grove, California, United States, 91945
        • Forest Investigative Site 052
      • Oceanside, California, United States, 92056
        • Forest Investigative Site 042
      • Sherman Oaks, California, United States, 91403
        • Forest Investigative Site 016
      • Sherman Oaks, California, United States, 91403
        • Forest Investigative Site 037
      • Simi Valley, California, United States, 93065
        • Forest Investigative Site 043
    • Connecticut
      • Cromwell, Connecticut, United States, 06475
        • Forest Investigative Site 040
      • Norwich, Connecticut, United States, 06360
        • Forest Investigative Site 038
    • Florida
      • Bradenton, Florida, United States, 34201
        • Forest Investigative Site 023
      • Fort Myers, Florida, United States, 33912
        • Forest Investigative Site 018
      • Jacksonville, Florida, United States, 32256
        • Forest Investigative Site 001
      • Jacksonville Beach, Florida, United States, 32250
        • Forest Investigative Site 008
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site 057
      • Orlando, Florida, United States, 32801
        • Forest Investigative Site 009
      • West Palm Beach, Florida, United States, 33407
        • Forest Investigative Site 045
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Forest Investigative Site 034
      • Smyrna, Georgia, United States, 30080
        • Forest Investigative Site 049
    • Illinois
      • Schaumburg, Illinois, United States, 60194
        • Forest Investigative Site 019
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Forest Investigative Site 020
      • Watertown, Massachusetts, United States, 02472
        • Forest Investigative Site 051
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site 044
    • New York
      • Brooklyn, New York, United States, 11235
        • Forest Investigative Site 031
      • Cedarhurst, New York, United States, 11516
        • Forest Investigative Site 036
      • Mount Kisco, New York, United States, 10549
        • Forest Investigative Site 013
      • New York, New York, United States, 10003
        • Forest Investigative Site 003
      • New York, New York, United States, 10168
        • Forest Investigative Site 005
      • Rochester, New York, United States, 14618
        • Forest Investigative Site 055
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Forest Investigative Site 058
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Forest Investigative Site 011
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Forest Investigative Site 035
    • Oregon
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site 046
      • Salem, Oregon, United States, 97301
        • Forest Investigative Site 041
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Forest Investigative Site 012
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 030
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 033
    • Texas
      • Dallas, Texas, United States, 75243
        • Forest Investigative Site 054
      • Houston, Texas, United States, 77090
        • Forest Investigative Site 059
    • Utah
      • Murray, Utah, United States, 84123
        • Forest Investigative Site 014
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Forest Investigative Site 010
      • Roanoke, Virginia, United States, 24014
        • Forest Investigative Site 056
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223
        • Forest Investigative Site 026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
  • The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
  • The participant must have at least 3 lifetime episodes of MDD (including the current episode)

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
  • Participants who are considered a suicide risk
  • History of non-response to 2 or more antidepressants (after adequate treatment)
  • Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
  • Panic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label FETZIMA®
FETZIMA® (levomilnacipran extended release [ER]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period.
Drug: Levomilnacipran ER
Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
Other Names:
  • FETZIMA®
Placebo Comparator: Double-Blind Placebo
Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.
Drug: Placebo
Dose-matched placebo taken orally once daily.
Experimental: Double-Blind FETZIMA®
FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
Drug: Levomilnacipran ER
Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
Other Names:
  • FETZIMA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Relapse During the Double-Blind Treatment Period (DBTP)
Time Frame: From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)
Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a >/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening of depression as determined by the investigator, or need for alternative treatment of depressive symptoms as determined by the Investigator; 2) Montgomery-Asberg Depression Rating Scale (MADRS) total score >/= 18 (range 0 to 60) at 2 consecutive visits (second visit within 7 to 14 days after the first visit at which the MADRS total score was ≥ 18). Participant was considered censored at the last visit during DBTP if participant did not meet the relapse criteria during DBTP.
From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Raffaele Migliore, Forest Research Institute, Inc., an affiliate of Allergan, plc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2014

Primary Completion (Actual)

September 16, 2016

Study Completion (Actual)

September 16, 2016

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVM-MD-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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