Overview

This trial is active, not recruiting.

Condition depressive disorder, major
Treatments levomilnacipran er, placebo
Phase phase 4
Sponsor Forest Laboratories
Start date November 2014
End date October 2017
Trial size 640 participants
Trial identifier NCT02288325, LVM-MD-15

Summary

This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse (MDD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
40mg, 80mg or 120mg levomilnacipran ER (Extended Release)
levomilnacipran er Fetzima
Once daily, oral administration
(Placebo Comparator)
Dose-matched placebo
placebo
Once daily, oral administration

Primary Outcomes

Measure
Time to first relapse measured in days during the double-blind treatment period.
time frame: Number of days from the randomization (Week 20) date to the relapse date during the 26-week double-blind treatment phase (up to Week 46)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Men and Women 18-70 - Currently meet the DSM-V criteria for Major Depressive Disorder (MDD) - The patient must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months - The patient 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 - Patients who are considered a suicide risk - History of non-response to 2 or more antidepressants (after adequate treatment) - Patients who have a history of meeting The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for manic, hypomanic, or mixed episodes schizophrenia or other psychotic disorder obsessive-compulsive disorder - Panic disorder

Additional Information

Official title A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Forest Laboratories.