CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
Levomilnacipran ER +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/NCT03569475
NCT03569475Phase 3Completed
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A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder

Allergan·interventional·Posted Jun 26, 2018·Updated Mar 25, 2022

In Brief

A Phase 3 clinical trial evaluating Levomilnacipran ER, Fluoxetine, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 501 participants across 51 sites.

Detailed Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartJul 6, 2018
Primary CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.0 years ago

Interventions

Levomilnacipran ERdrug

Levomilnacipran extended-release oral capsules

Fluoxetinedrug

Fluoxetine oral capsules

Placebodrug

Matching placebo oral capsules