Last updated on January 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Endogenous depression | Major depression
  • Age: Between 12 - 17 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  1. Male or female outpatients;12-17 years of age
  2. 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)
  3. Score 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
  4. Clinical Global Impressions-Severity (CGI-S) score 4 at Visits 1 and 2
  5. Reliable caregiver
  6. Physical examination, vital signs, clinical laboratory tests, and ECG normal or not clinically significant

Key Psychiatric Exclusion Criteria:

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

Key Treatment-Related Exclusion Criteria:

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

Other Key Medical Exclusion Criteria:

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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