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Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

NCT02431806 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2020-09-07

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

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

DRUG

Levomilnacipran

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

DRUG

Fluoxetine

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

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Daniel Radecki · Forest Research Institute, Inc., an affiliate of Allergan, plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2019-08-19
Completion
2019-08-19
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

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 NCT02431806 on ClinicalTrials.gov