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Trial record 1 of 1 for:    NCT02431806
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Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02431806
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: Levomilnacipran Drug: Fluoxetine Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder
Actual Study Start Date : June 23, 2015
Actual Primary Completion Date : August 19, 2019
Actual Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
Drug: Placebo
Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.

Experimental: Levomilnacipran 40 mg
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Drug: Levomilnacipran
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
Other Name: Fetzima

Experimental: Levomilnacipran 80 mg
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
Drug: Levomilnacipran
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
Other Name: Fetzima

Active Comparator: Fluoxetine 20 mg
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Drug: Fluoxetine
Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.
Other Name: Prozac




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431806


Locations
Show Show 49 study locations
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Daniel Radecki Forest Research Institute, Inc., an affiliate of Allergan, plc
  Study Documents (Full-Text)

Documents provided by Forest Laboratories:
Statistical Analysis Plan  [PDF] October 3, 2019
Study Protocol  [PDF] March 25, 2019

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02431806    
Obsolete Identifiers: NCT03087916
Other Study ID Numbers: LVM-MD-11
First Posted: May 1, 2015    Key Record Dates
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Milnacipran
Fluoxetine
Levomilnacipran
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents