Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

To Learn more

CW ID: 212058
Date Last Changed: February 15, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
12 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Forest Laboratories
Duration
10 Weeks
Facility Type
Out-Patient

Eligibility

Key Inclusion Criteria:

  • Male or female outpatients;12-17 years of age
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD) , confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
  • Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
  • Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
  • Reliable caregiver
  • Physical examination, vital signs, clinical laboratory tests, and ECG normal or not clinically significant

Key Psychiatric Exclusion Criteria:

  • DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
  • Mental retardation or amnestic or other cognitive disorders
    • Significant suicide risk
    • Suicide attempt within the past year OR
    • Investigator judgment (based on psychiatric interview and C-SSRS)

Key Treatment-Related Exclusion Criteria:

  • Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
  • Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

  • Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect patient safety
  • Liver enzyme tests (aspartate aminotransferase) AST and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
  • Clinically significant cardiovascular disorders
  • Seizure disorder or risk of seizure
  • Drug or alcohol abuse or dependence (within the past year)
  • Positive urine drug screen or blood alcohol

More Info

Protocol Number: LVM-MD-11

Contact

Alexis Wolfe
University of South Florida- Rothman Center for Pediatric Neuropsychiatry
800 6th Street South
St. Petersburg, FL 33701
Phone: 727-767-8230

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