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

• Status: Completed
• Trial end date: 2019-08-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Fluoxetine; Levomilnacipran; Milnacipran

Criteria

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 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 electrocardiogram (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 Columbia-Suicide Severity Rating Scale (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 participants 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