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Trial record 1 of 1 for:    lvm-md-11
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Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder

This study is currently recruiting participants.
Verified November 2017 by Forest Laboratories
Sponsor:
ClinicalTrials.gov Identifier:
NCT02431806
First Posted: May 1, 2015
Last Update Posted: November 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  Purpose
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 Intervention Phase
Major Depressive Disorder Drug: Placebo Drug: Levomilnacipran ER Drug: Fluoxetine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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."


Estimated Enrollment: 660
Actual Study Start Date: June 23, 2015
Estimated Study Completion Date: March 6, 2018
Estimated Primary Completion Date: March 6, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients randomized to the placebo arm will take placebo capsules once daily orally during the double-blind treatment period.
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.
Drug: Levomilnacipran ER
Other Name: Fetzima
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.
Drug: Levomilnacipran ER
Other Name: Fetzima
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.
Drug: Fluoxetine
Other Name: Prozac

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.

  Eligibility

Information from the National Library of Medicine

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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:

  1. Male or female outpatients;12-17 years of age
  2. 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)
  3. Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
  4. Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
  5. Reliable caregiver
  6. Physical examination, vital signs, clinical laboratory tests, and ECG normal or not clinically significant

Key Psychiatric Exclusion Criteria:

  1. DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
  2. Mental retardation or amnestic or other cognitive disorders

    • 3) Significant suicide risk:
    • Suicide attempt within the past year OR
    • Investigator judgment (based on psychiatric interview and C-SSRS)

Key Treatment-Related Exclusion Criteria:

  1. Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
  2. Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

  1. Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect patient safety
  2. Liver enzyme tests (aspartate aminotransferase) AST and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
  3. Clinically significant cardiovascular disorders
  4. Seizure disorder or risk of seizure
  5. Drug or alcohol abuse or dependence (within the past year)
  6. Positive urine drug screen or blood alcohol
  Contacts and Locations
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


Contacts
Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

  Show 90 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: William McLaughlin Forest Research Institute, Inc., an affiliate of Allergan, plc
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02431806     History of Changes
Obsolete Identifiers: NCT03087916
Other Study ID Numbers: LVM-MD-11
First Submitted: April 28, 2015
First Posted: May 1, 2015
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Fluoxetine
Milnacipran
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
Adrenergic Uptake Inhibitors
Adrenergic Agents