Clinical trial NCT02288325: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Fetzima
Relapse-prevention
Placebo-controlled
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 644
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Time to First Relapse During the Double-Blind Treatment Period (DBTP)
timeFrame: From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 053
state: Alabama
city: Dothan
country: United States
facility: Forest Investigative Site 050
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 039
state: Arizona
city: Beverly Hills
country: United States
facility: Forest Investigative Site 048
state: California
city: Chino
country: United States
facility: Forest Investigative Site 047
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 028
state: California
city: Encino
country: United States
facility: Forest Investigative Site 021
state: California
city: Lemon Grove
country: United States
facility: Forest Investigative Site 052
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 042
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 016
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 037
state: California
city: Simi Valley
country: United States
facility: Forest Investigative Site 043
state: California
city: Cromwell
country: United States
facility: Forest Investigative Site 040
state: Connecticut
city: Norwich
country: United States
facility: Forest Investigative Site 038
state: Connecticut
city: Bradenton
country: United States
facility: Forest Investigative Site 023
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site 018
state: Florida
city: Jacksonville Beach
country: United States
facility: Forest Investigative Site 008
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site 057
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 009
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 045
state: Florida
city: Alpharetta
country: United States
facility: Forest Investigative Site 034
state: Georgia
city: Smyrna
country: United States
facility: Forest Investigative Site 049
state: Georgia
city: Schaumburg
country: United States
facility: Forest Investigative Site 019
state: Illinois
city: Methuen
country: United States
facility: Forest Investigative Site 020
state: Massachusetts
city: Watertown
country: United States
facility: Forest Investigative Site 051
state: Massachusetts
city: Cherry Hill
country: United States
facility: Forest Investigative Site 044
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 031
state: New York
city: Cedarhurst
country: United States
facility: Forest Investigative Site 036
state: New York
city: Mount Kisco
country: United States
facility: Forest Investigative Site 013
state: New York
city: New York
country: United States
facility: Forest Investigative Site 003
state: New York
city: New York
country: United States
facility: Forest Investigative Site 005
state: New York
city: Rochester
country: United States
facility: Forest Investigative Site 055
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 058
state: North Carolina
city: Dayton
country: United States
facility: Forest Investigative Site 011
state: Ohio
city: Tulsa
country: United States
facility: Forest Investigative Site 035
state: Oklahoma
city: Portland
country: United States
facility: Forest Investigative Site 046
state: Oregon
city: Salem
country: United States
facility: Forest Investigative Site 041
state: Oregon
city: Media
country: United States
facility: Forest Investigative Site 012
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative Site 030
state: Tennessee
city: Memphis
country: United States
facility: Forest Investigative Site 033
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 054
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 059
state: Texas
city: Murray
country: United States
facility: Forest Investigative Site 014
state: Utah
city: Charlottesville
country: United States
facility: Forest Investigative Site 010
state: Virginia
city: Roanoke
country: United States
facility: Forest Investigative Site 056
state: Virginia
city: Brown Deer
country: United States
facility: Forest Investigative Site 026
state: Wisconsin
Study officials:
affiliation: Forest Research Institute, Inc., an affiliate of Allergan, plc
name: Raffaele Migliore
role: STUDY_DIRECTOR
References: