CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 552 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02431806
NCT02431806Phase 3Completed
CompareCT.gov

A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder

Forest Laboratories·interventional·Posted May 1, 2015·Updated Sep 7, 2020

In Brief

A Phase 3 clinical trial evaluating Placebo, Levomilnacipran, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 552 participants across 49 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 1, 2015
Enrollment StartJun 23, 2015
Primary CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.2 years ago

Interventions

Placebodrug

Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.

Levomilnaciprandrug

Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.

Fluoxetinedrug

Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.