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

Phase 4

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Levomilnacipran ER; Drug: Placebo

• Registration Number: NCT02288325
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-11
• Study Start: 2014-11-18
• Primary Completion: 2016-09-16
• Study Completion: 2016-09-16
• Status Verified: 2018-09
• Results First Submitted: 2018-09-28
• Results First Submitted QC: 2018-09-28
• Last Update Submitted: 2018-09-28
• Results First Posted: 2018-10-29
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 644

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double-Blind FETZIMA®	Levomilnacipran ER	FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
Open-Label FETZIMA®	Levomilnacipran ER	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.
Double-Blind Placebo	Placebo	Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.

Primary Outcome Measures

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

Trial Locations

Locations (47)

Forest Investigative Site 053; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 050; 🇺🇸 Dothan, Alabama, United States

Forest Investigative Site 039; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 048; 🇺🇸 Beverly Hills, California, United States

Forest Investigative Site 047; 🇺🇸 Chino, California, United States

Forest Investigative Site 028; 🇺🇸 Costa Mesa, California, United States

Forest Investigative Site 021; 🇺🇸 Encino, California, United States

Forest Investigative Site 052; 🇺🇸 Lemon Grove, California, United States

Forest Investigative Site 042; 🇺🇸 Oceanside, California, United States

Forest Investigative Site 016; 🇺🇸 Sherman Oaks, California, United States

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