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Status:

COMPLETED

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

Lead Sponsor:

Forest Laboratories

Conditions:

Depressive Disorder, Major

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

Brief Summary

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).

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 18 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 16 2016

    Estimated Enrollment :

    644 Patients enrolled

    Trial Details

    Trial ID

    NCT02288325

    Start Date

    November 18 2014

    End Date

    September 16 2016

    Last Update

    October 29 2018

    Active Locations (47)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (47 locations)

    1

    Forest Investigative Site 053

    Birmingham, Alabama, United States, 35294

    2

    Forest Investigative Site 050

    Dothan, Alabama, United States, 36303

    3

    Forest Investigative Site 039

    Phoenix, Arizona, United States, 85032

    4

    Forest Investigative Site 048

    Beverly Hills, California, United States, 90210