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NCT Number: NCT02431806

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

INSPIRA Clinical Research, San Juan, Puerto Rico

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About this study

Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be approximately 10 weeks in duration:

  • 1-week screening/washout period
  • 8-week double-blind treatment period
  • 1-week double-blind down-taper period

Participants who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1 of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or fluoxetine 20 mg/day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.

Levomilnacipran

Drug

Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.

Other names: Fetzima

Fluoxetine

Drug

Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.

Other names: Prozac

Primary outcomes

  1. Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score

    Time frame: Baseline (Week 0) to Week 8

    CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.

Secondary outcomes

  1. Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale

    Time frame: Baseline (Week 0) to Week 8

    The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 1, 2015
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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