A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
Completed
Forest Laboratories
Phase 4
2014-11-18
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).
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
Completed
Forest Laboratories
Phase 3
2015-06-23
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major
Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK)
data to guide dose selection for future pediatric studies of levomilnacipran.
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD
Completed
Forest Laboratories
Phase 3
2017-01-23
This study's primary objective is to compare the efficacy and tolerability of switching
patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new
treatment (quetiapine) to the participants' existing treatment with people diagnosed with
depression (major depression disorder).
The secondary objective is to examine the response and remission rates following the switch
from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with
examining changes in neurocognitive and apathy measures after the switch.
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