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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levomilnacipran ER
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Fetzima, Relapse-prevention, Placebo-controlled

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 053
  • Forest Investigative Site 050
  • Forest Investigative Site 039
  • Forest Investigative Site 048
  • Forest Investigative Site 047
  • Forest Investigative Site 028
  • Forest Investigative Site 021
  • Forest Investigative Site 052
  • Forest Investigative Site 042
  • Forest Investigative Site 016
  • Forest Investigative Site 037
  • Forest Investigative Site 043
  • Forest Investigative Site 040
  • Forest Investigative Site 038
  • Forest Investigative Site 023
  • Forest Investigative Site 018
  • Forest Investigative Site 008
  • Forest Investigative Site 001
  • Forest Investigative Site 057
  • Forest Investigative Site 009
  • Forest Investigative Site 045
  • Forest Investigative Site 034
  • Forest Investigative Site 049
  • Forest Investigative Site 019
  • Forest Investigative Site 020
  • Forest Investigative Site 051
  • Forest Investigative Site 044
  • Forest Investigative Site 031
  • Forest Investigative Site 036
  • Forest Investigative Site 013
  • Forest Investigative Site 003
  • Forest Investigative Site 005
  • Forest Investigative Site 055
  • Forest Investigative Site 058
  • Forest Investigative Site 011
  • Forest Investigative Site 035
  • Forest Investigative Site 046
  • Forest Investigative Site 041
  • Forest Investigative Site 012
  • Forest Investigative Site 030
  • Forest Investigative Site 033
  • Forest Investigative Site 054
  • Forest Investigative Site 059
  • Forest Investigative Site 014
  • Forest Investigative Site 010
  • Forest Investigative Site 056
  • Forest Investigative Site 026

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Open-Label FETZIMA®

Double-Blind Placebo

Double-Blind FETZIMA®

Arm Description

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.

Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.

FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.

Outcomes

Primary Outcome Measures

Time to First Relapse During the Double-Blind Treatment Period (DBTP)
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.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2014
Last Updated
September 28, 2018
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT02288325
Brief Title
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
Official Title
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 18, 2014 (Actual)
Primary Completion Date
September 16, 2016 (Actual)
Study Completion Date
September 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Fetzima, Relapse-prevention, Placebo-controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
644 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label FETZIMA®
Arm Type
Experimental
Arm Description
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.
Arm Title
Double-Blind Placebo
Arm Type
Placebo Comparator
Arm Description
Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.
Arm Title
Double-Blind FETZIMA®
Arm Type
Experimental
Arm Description
FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
Intervention Type
Drug
Intervention Name(s)
Levomilnacipran ER
Other Intervention Name(s)
FETZIMA®
Intervention Description
Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-matched placebo taken orally once daily.
Primary Outcome Measure Information:
Title
Time to First Relapse During the Double-Blind Treatment Period (DBTP)
Description
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.
Time Frame
From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele Migliore
Organizational Affiliation
Forest Research Institute, Inc., an affiliate of Allergan, plc
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 053
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Forest Investigative Site 050
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Forest Investigative Site 039
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Forest Investigative Site 048
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 047
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Forest Investigative Site 028
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 021
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Forest Investigative Site 052
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Forest Investigative Site 042
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 016
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 037
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Investigative Site 043
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Forest Investigative Site 040
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06475
Country
United States
Facility Name
Forest Investigative Site 038
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Forest Investigative Site 023
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Forest Investigative Site 018
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 008
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Forest Investigative Site 001
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Forest Investigative Site 057
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 009
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Forest Investigative Site 045
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Forest Investigative Site 034
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Forest Investigative Site 049
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Forest Investigative Site 019
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Forest Investigative Site 020
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Forest Investigative Site 051
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Forest Investigative Site 044
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 031
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Forest Investigative Site 036
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Forest Investigative Site 013
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Forest Investigative Site 003
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 005
City
New York
State/Province
New York
ZIP/Postal Code
10168
Country
United States
Facility Name
Forest Investigative Site 055
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Forest Investigative Site 058
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Forest Investigative Site 011
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 035
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Forest Investigative Site 046
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 041
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Forest Investigative Site 012
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site 030
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 033
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 054
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Forest Investigative Site 059
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Forest Investigative Site 014
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Forest Investigative Site 010
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Forest Investigative Site 056
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Forest Investigative Site 026
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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