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

Depressive Disorder, Major Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288325
• Other study ID #: LVM-MD-15
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2014
• Est. completion date: September 16, 2016

Study information

• Verified date: September 2018
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 644
• Est. completion date: September 16, 2016
• Est. primary completion date: September 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Recurrence

Intervention

Drug:
• Levomilnacipran ER
Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
• Placebo
Dose-matched placebo taken orally once daily.

Locations

Country	Name	City	State
United States	Forest Investigative Site 034	Alpharetta	Georgia
United States	Forest Investigative Site 048	Beverly Hills	California
United States	Forest Investigative Site 053	Birmingham	Alabama
United States	Forest Investigative Site 023	Bradenton	Florida
United States	Forest Investigative Site 031	Brooklyn	New York
United States	Forest Investigative Site 026	Brown Deer	Wisconsin
United States	Forest Investigative Site 036	Cedarhurst	New York
United States	Forest Investigative Site 058	Charlotte	North Carolina
United States	Forest Investigative Site 010	Charlottesville	Virginia
United States	Forest Investigative Site 044	Cherry Hill	New Jersey
United States	Forest Investigative Site 047	Chino	California
United States	Forest Investigative Site 028	Costa Mesa	California
United States	Forest Investigative Site 040	Cromwell	Connecticut
United States	Forest Investigative Site 054	Dallas	Texas
United States	Forest Investigative Site 011	Dayton	Ohio
United States	Forest Investigative Site 050	Dothan	Alabama
United States	Forest Investigative Site 021	Encino	California
United States	Forest Investigative Site 018	Fort Myers	Florida
United States	Forest Investigative Site 059	Houston	Texas
United States	Forest Investigative Site 001	Jacksonville	Florida
United States	Forest Investigative Site 008	Jacksonville Beach	Florida
United States	Forest Investigative Site 057	Kissimmee	Florida
United States	Forest Investigative Site 052	Lemon Grove	California
United States	Forest Investigative Site 012	Media	Pennsylvania
United States	Forest Investigative Site 030	Memphis	Tennessee
United States	Forest Investigative Site 033	Memphis	Tennessee
United States	Forest Investigative Site 020	Methuen	Massachusetts
United States	Forest Investigative Site 013	Mount Kisco	New York
United States	Forest Investigative Site 014	Murray	Utah
United States	Forest Investigative Site 003	New York	New York
United States	Forest Investigative Site 005	New York	New York
United States	Forest Investigative Site 038	Norwich	Connecticut
United States	Forest Investigative Site 042	Oceanside	California
United States	Forest Investigative Site 009	Orlando	Florida
United States	Forest Investigative Site 039	Phoenix	Arizona
United States	Forest Investigative Site 046	Portland	Oregon
United States	Forest Investigative Site 056	Roanoke	Virginia
United States	Forest Investigative Site 055	Rochester	New York
United States	Forest Investigative Site 041	Salem	Oregon
United States	Forest Investigative Site 019	Schaumburg	Illinois
United States	Forest Investigative Site 016	Sherman Oaks	California
United States	Forest Investigative Site 037	Sherman Oaks	California
United States	Forest Investigative Site 043	Simi Valley	California
United States	Forest Investigative Site 049	Smyrna	Georgia
United States	Forest Investigative Site 035	Tulsa	Oklahoma
United States	Forest Investigative Site 051	Watertown	Massachusetts
United States	Forest Investigative Site 045	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)