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

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Depressive Disorder, Major

Treatments: Drug: Levomilnacipran ER; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02288325

LVM-MD-15

Details and patient eligibility

About

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).

Enrollment: 644 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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644 participants in 3 patient groups, including a placebo group

Open-Label FETZIMA®

Experimental group

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.

Treatment:

Drug: Levomilnacipran ER

Double-Blind Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Double-Blind FETZIMA®

Experimental group

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.

Treatment:

Drug: Levomilnacipran ER