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

NCT02288325 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2018-10-29

Study results available
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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

Interventions

DRUG

Levomilnacipran ER

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

DRUG

Placebo

Dose-matched placebo taken orally once daily.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Raffaele Migliore · Forest Research Institute, Inc., an affiliate of Allergan, plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-18
Primary Completion
2016-09-16
Completion
2016-09-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288325 on ClinicalTrials.gov