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Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric (7-17 Years) With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03569475
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD)

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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 Pediatric Patients 7-17 Years With Major Depressive Disorder
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : May 19, 2021
Estimated Study Completion Date : October 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levomilnacipran ER
patients will take levomilnacipran 10 mg/day on Days 1-3, 20 mg/day on Days 4-7, and 40 mg/day during weeks 2 through 8 of the double blinded treatment and 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days in the down-taper period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day is permitted at Week 3 through 8 of the double blinded treatment. in the down-taper period. the patient will take levomilnacipran 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days
Drug: Levomilnacipran ER
During the double-blind treatment period, patients will take levomilnacipran 10 mg/day on Days 1-3, 20 mg/day on Days 4-7, and 40 mg/day during Weeks 2 through 8. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day is permitted at Week 3. During the down-taper period, patients will take levomilnacipran 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days

Active Comparator: Fluoxetine 20 mg
Patients randomized to the Fluoxetine 20 mg arm will take Week 1, 10mg/day; week 2 through week 8, 20 mg/day
Drug: Fluoxetine
During the double-blind treatment period, patients will take Fluoxetine 10 mg/day on Days 1-7, and then 20 mg/day during Weeks 2 through Week 8. During the down-taper period, patients will take Fluoxetine 10 mg/day for 7 days.

Placebo Comparator: Placebo
Patients randomized to the placebo arm will take placebo capsules once daily through week 8
Drug: Placebo
Patients randomized to the placebo arm will take placebo capsules once daily




Primary Outcome Measures :
  1. Change from baseline in Children's Depression Rating Scale- Revised (CDRS-R) [ Time Frame: 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 ordinally-scaled items that evaluate the presence and severity of symptoms commonly associated with childhood depression. The CDRS-R total score ranges from 17 to 113.


Secondary Outcome Measures :
  1. Change from baseline in Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: 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 a "normal, not at all ill" and 7 indicating "among the most extremely ill patients."



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet Diagnostic and statistical manual of mental disorders fifth edition (DSM-5) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders - Present and Lifetime (K-SADS-PL)
  • Patients must have a score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
  • Patients must have a Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
  • Patients must have a caregiver who can and is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of investigational product, and accompany the patient to all study visits
  • Female patients of childbearing potential who are sexually active must agree to use a reliable method of contraception that will continue for the duration of the study and within 30 days following the end of study participation.
  • A sexually active male patient must agree to use contraception as detailed below during the treatment period and for at least 30 days after the last dose of investigational product.

Exclusion Criteria:

  • DSM-5-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment.
  • Prior diagnosis of mental retardation or amnestic or other cognitive disorders based on DSM-5 criteria
  • Imminent risk of injuring self or others or causing damage to property as judged by the Investigator
  • Suicide risk as determined by meeting either of the following criteria:

    • Any suicide attempt within the past year
    • Significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS) treatment-Related Criteria
  • History of allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other Selective serotonin reuptake inhibitors (SSRI) or Serotonin and norepinephrine reuptake inhibitors (SNRI) or known hypersensitivity to the investigational products' non-medicinal ingredients including gelatin and cellulose
  • Patients requiring prohibited concomitant medication or herbal supplements that could not be discontinued or switched to an allowable alternative medication and stabilized for at least 2 weeks preceding Visit 2 (Baseline)
  • Patients taking any psychoactive drug or psychoactive herbal remedy within 5 half-lives before Baseline (Visit 2), Patients who have ever been treated with a depot antipsychotic must also be excluded
  • Patients who have initiated or terminated psychotherapy or behavior therapy within1 month before Visit 1 (Screening), or who plan to initiate or change such therapies during the course of the study Other Medical criteria
  • A clinically significant disease state that, in the investigator's opinion, might indicate that the patient is unsuitable for the study
  • Any cardiovascular disease or condition that is clinically significant, unstable, or decompensated.
  • Hypo- or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 3 months before Visit 1 (Screening)
  • Any condition that would be expected to affect drug absorption (eg, gastric bypass surgery)
  • History of seizure disorder (except simple childhood febrile seizures before age 5), unexplained syncope or black-out episodes, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes the patient toward a risk for seizure
  • History of drug or alcohol abuse or dependence within the past year
  • Pregnant, breastfeeding, and/or planning to become pregnant and/or breastfeed during the study or within 30 days following the end of study participation

Other Criteria

  • Patients who are unable to swallow capsules
  • Treatment with any investigational product within 3 months (or at least 5 half-lives, whichever is longer) of Visit 1. Treatment with any investigational product other than those provided by AGN during study participation will be a protocol violation, and the patient will be terminated from this study
  • Employee or immediate relative of an employee of AGN, any of its affiliates or partners, or of the study center Patients or patients whose parent/guardian/LAR and/or caregivers are unable to speak and understand English (or their native language if this can be accommodated by the site and is approved by the Sponsor) sufficiently to understand the nature of the study, to provide informed assent/consent, or to allow the completion of all study assessments
  • Unable or unlikely to comply with the study protocol or are unsuitable for any other reason, as judged by the Investigator

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): NCT03569475


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

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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Daniel Radecki, PhD Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03569475     History of Changes
Other Study ID Numbers: LVM-MD-14
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019

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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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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
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