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

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ClinicalTrials.gov Identifier: NCT02288325
Recruitment Status : Completed
First Posted : November 11, 2014
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
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 in major depressive disorder (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: Triple (Participant, 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
Actual Study Start Date : November 18, 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: 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 Name: 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 Name: FETZIMA®




Primary Outcome Measures :
  1. 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.



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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

  • 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

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: Raffaele Migliore 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
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: September 2018

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