Phase 3
Completed N=552
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
Source: ClinicalTrials.gov NCT02431806 ↗Enrolled (actual)
552
Serious AEs
1.1%
Results posted
Sep 2020
Primary outcomePrimary: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score — -22.90; -23.28; -22.64; -24.37 score on a scale — p=0.8035
◆ Published Evidence
Emerging
5citations · ~3 / year
Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies.
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.
Linked Publications
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Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score |
-22.90; -23.28; -22.64; -24.37 | 0.8035 |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale |
-1.54; -1.52; -1.52; -1.68 | 0.8788 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02431806) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.