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Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

NCT01377194 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2013-10-29

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).

Conditions

Interventions

DRUG

Levomilnacipran ER

Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

DRUG

Levomilnacipran ER

Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks

DRUG

Placebo

Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Carl Gommoll, MS · Forest Research Institute, a subsidiary of Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States
  • Canada

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 NCT01377194 on ClinicalTrials.gov