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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

Tracking Information
First Submitted Date  ICMJE June 15, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE July 6, 2018
Estimated Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03569475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
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."
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 Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric (7-17 Years) With Major Depressive Disorder
Official Title  ICMJE 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
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)
Detailed Description Not Provided
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: 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
  • 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.
  • Drug: Placebo
    Patients randomized to the placebo arm will take placebo capsules once daily
Study Arms  ICMJE
  • 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
    Intervention: Drug: Levomilnacipran ER
  • 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
    Intervention: Drug: Fluoxetine
  • Placebo Comparator: Placebo
    Patients randomized to the placebo arm will take placebo capsules once daily through week 8
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2018)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 21, 2021
Estimated Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03569475
Other Study ID Numbers  ICMJE LVM-MD-14
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 Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Radecki, PhD Allergan
PRS Account Allergan
Verification Date August 2019

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