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Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder

NCT03569475 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2022-03-25

Study results available
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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).

Conditions

Interventions

DRUG

Levomilnacipran ER

Levomilnacipran extended-release oral capsules

DRUG

Fluoxetine

Fluoxetine oral capsules

DRUG

Placebo

Matching placebo oral capsules

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Daniel Radecki, PhD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2021-03-01
Completion
2021-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03569475 on ClinicalTrials.gov