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

NCT02288325 | Completed Phase 4 Results

• 1 other identifier: LVM-MD-15
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 47

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).

Conditions

Depressive Disorder, Major

Keywords

Fetzima; Relapse-prevention; Placebo-controlled

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Open-Label FETZIMA®

EXPERIMENTAL

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

Double-Blind Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Double-Blind FETZIMA®

EXPERIMENTAL

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

Interventions

Levomilnacipran ER DRUG

Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.

Also known as: FETZIMA®

Double-Blind FETZIMA®; Open-Label FETZIMA®

Placebo DRUG

Dose-matched placebo taken orally once daily.

Double-Blind Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (47)

Forest Investigative Site 053

Birmingham, Alabama, 35294, United States

Location

Forest Investigative Site 050

Dothan, Alabama, 36303, United States

Location

Forest Investigative Site 039

Phoenix, Arizona, 85032, United States

Location

Forest Investigative Site 048

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 047

Chino, California, 91710, United States

Location

Forest Investigative Site 028

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 021

Encino, California, 91316, United States

Location

Forest Investigative Site 052

Lemon Grove, California, 91945, United States

Location

Forest Investigative Site 042

Oceanside, California, 92056, United States

Location

Forest Investigative Site 016

Sherman Oaks, California, 91403, United States

Location

Forest Investigative Site 037

Sherman Oaks, California, 91403, United States

Location

Forest Investigative Site 043

Simi Valley, California, 93065, United States

Location

Forest Investigative Site 040

Cromwell, Connecticut, 06475, United States

Location

Forest Investigative Site 038

Norwich, Connecticut, 06360, United States

Location

Forest Investigative Site 023

Bradenton, Florida, 34201, United States

Location

Forest Investigative Site 018

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 001

Jacksonville, Florida, 32256, United States

Location

Forest Investigative Site 008

Jacksonville Beach, Florida, 32250, United States

Location

Forest Investigative Site 057

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site 009

Orlando, Florida, 32801, United States

Location

Forest Investigative Site 045

West Palm Beach, Florida, 33407, United States

Location

Forest Investigative Site 034

Alpharetta, Georgia, 30005, United States

Location

Forest Investigative Site 049

Smyrna, Georgia, 30080, United States

Location

Forest Investigative Site 019

Schaumburg, Illinois, 60194, United States

Location

Forest Investigative Site 020

Methuen, Massachusetts, 01844, United States

Location

Forest Investigative Site 051

Watertown, Massachusetts, 02472, United States

Location

Forest Investigative Site 044

Cherry Hill, New Jersey, 08002, United States

Location

Forest Investigative Site 031

Brooklyn, New York, 11235, United States

Location

Forest Investigative Site 036

Cedarhurst, New York, 11516, United States

Location

Forest Investigative Site 013

Mount Kisco, New York, 10549, United States

Location

Forest Investigative Site 003

New York, New York, 10003, United States

Location

Forest Investigative Site 005

New York, New York, 10168, United States

Location

Forest Investigative Site 055

Rochester, New York, 14618, United States

Location

Forest Investigative Site 058

Charlotte, North Carolina, 28211, United States

Location

Forest Investigative Site 011

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 035

Tulsa, Oklahoma, 74104, United States

Location

Forest Investigative Site 046

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 041

Salem, Oregon, 97301, United States

Location

Forest Investigative Site 012

Media, Pennsylvania, 19063, United States

Location

Forest Investigative Site 030

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 033

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 054

Dallas, Texas, 75243, United States

Location

Forest Investigative Site 059

Houston, Texas, 77090, United States

Location

Forest Investigative Site 014

Murray, Utah, 84123, United States

Location

Forest Investigative Site 010

Charlottesville, Virginia, 22911, United States

Location

Forest Investigative Site 056

Roanoke, Virginia, 24014, United States

Location

Forest Investigative Site 026

Brown Deer, Wisconsin, 53223, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Levomilnacipran

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Milnacipran; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Raffaele Migliore

  Forest Research Institute, Inc., an affiliate of Allergan, plc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 11, 2014
• Study Start: November 18, 2014
• Primary Completion: September 16, 2016
• Study Completion: September 16, 2016
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-09

Locations

US (47)