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Trial record 1 of 1 for:    lvm-md-11 | adolescent | Oklahoma, United States
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Safety and Efficacy of Levomilnacipran ER in Adolescent Patients 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
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE April 28, 2015
First Posted Date  ICMJE May 1, 2015
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE June 23, 2015
Actual Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Change in Children's Depression Rating Scale-Revised (CDRS-R) total score [ Time Frame: From Baseline to end of Week 8 ]
The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years and contains 17 items that evaluate the presence and severity of symptoms commonly associated with childhood depression. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Change in Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: From Baseline to end of Week 8 ]
The CGI-S is a clinician-rated scale used to rate the severity of the patient's current state of mental illness compared with an MDD patient population. The patient will be rated on a scale from 1 to 7, with 1 indicating "normal, not at all ill" and 7 indicating "among the most extremely ill patients."
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder
Official Title  ICMJE A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder
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.
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

Patients 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Placebo
  • Drug: Levomilnacipran ER
    Other Name: Fetzima
  • Drug: Fluoxetine
    Other Name: Prozac
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients randomized to the placebo arm will take placebo capsules once daily orally during the double-blind treatment period.
    Intervention: Drug: Placebo
  • Experimental: Levomilnacipran ER 40 mg
    Patients randomized to the levomilnacipran ER 40 mg arm will take over-encapsulated levomilnacipran ER 40 mg capsules once daily orally during the double-blind treatment period.
    Intervention: Drug: Levomilnacipran ER
  • Experimental: Levomilnacipran ER 80 mg
    Patients randomized to the levomilnacipran ER 80 mg arm will take two over-encapsulated levomilnacipran ER 40 mg capsules once daily orally during the double-blind treatment period.
    Intervention: Drug: Levomilnacipran ER
  • Active Comparator: Fluoxetine 20 mg
    Patients randomized to the fluoxetine 20 mg arm will take over-encapsulated fluoxetine 20 mg tablets once daily orally during the double-blind treatment period.
    Intervention: Drug: Fluoxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
544
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
480
Actual Study Completion Date  ICMJE August 19, 2019
Actual Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Major Depressive Disorder (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 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 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 patient 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States,   Puerto Rico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02431806
Other Study ID Numbers  ICMJE LVM-MD-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Radecki Forest Research Institute, Inc., an affiliate of Allergan, plc
PRS Account Forest Laboratories
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP