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A Multicenter, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT02288325
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Levomilnacipran ER Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 644 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder
Study Start Date : November 2014
Actual Primary Completion Date : September 16, 2016
Actual Study Completion Date : September 16, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levomilnacipran ER
40mg, 80mg or 120mg levomilnacipran ER (Extended Release)
Drug: Levomilnacipran ER
Once daily, oral administration
Other Name: Fetzima

Placebo Comparator: Placebo
Dose-matched placebo
Drug: Placebo
Once daily, oral administration




Primary Outcome Measures :
  1. Time to first relapse measured in days during the double-blind treatment period. [ Time Frame: Number of days from the randomization (Week 20) date to the relapse date during the 26-week double-blind treatment phase (up to Week 46) ]
    Comparison of the time to first relapse during the double-blind treatment period between placebo and the levomilnacipran ER treatment groups using the log-rank test based on the double-blind Intent-to-Treat (ITT) population. Time to first relapse is measured in days from randomization date to relapse date.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and Women 18-70
  • Currently meet the DSM-V criteria for Major Depressive Disorder (MDD)
  • The patient must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
  • The patient 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
  • Patients who are considered a suicide risk
  • History of non-response to 2 or more antidepressants (after adequate treatment)
  • Patients who have a history of meeting The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for manic, hypomanic, or mixed episodes schizophrenia or other psychotic disorder obsessive-compulsive disorder
  • Panic disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288325


  Show 47 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Rezwanur Rahman Forest Research Institute, Inc., an affiliate of Allergan, plc

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02288325     History of Changes
Other Study ID Numbers: LVM-MD-15
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Forest Laboratories:
Fetzima
Relapse-prevention
Placebo-controlled

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Recurrence
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Disease Attributes
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents