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A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03315793
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: Duloxetine Hydrochloride Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : February 4, 2020
Estimated Study Completion Date : February 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Duloxetine Hydrochloride
Duloxetine hydrochloride given orally.
 Drug: Duloxetine Hydrochloride
Administered orally
Other Name: LY248686
Placebo Comparator: Placebo
Placebo given orally.
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score [ Time Frame: Baseline, Week 6 ]
    Mean change from baseline on the CDRS-R total score


Secondary Outcome Measures :
  1. Percentage of Participants Whose CDRS-R Total Score Decreased by More than 30% from Baseline [ Time Frame: Week 6 ]
    Percentage of participants whose CDRS-R total score decreased by more than 30% from baseline

  2. Percentage of Participants Whose CDRS-R Total Score Decreased by More than 50% from Baseline [ Time Frame: Week 6 ]
    Percentage of participants whose CDRS-R total score decreased by more than 50% from baseline

  3. Percentage of Participants with Total CDRS-R Score ≤ 28 [ Time Frame: Week 6 ]
    Percentage of participants with total CDRS-R score ≤ 28

  4. Mean Change from Baseline on Clinical Global Impression-Severity (CGI-S) [ Time Frame: Baseline, Week 6 ]
    Mean change from baseline on CGI-S


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants diagnosed with Major Depressive Disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) ver.7.0.2.
  • Participants whose incipient age of depression was ≥7 years old.
  • Total score of CDRS-R is ≥40 and CGI-S score is ≥4 at both screening and baseline.

Exclusion Criteria:

  • Have remarkable response to psycho-education (defined as >30% decrease in the total score of CDRS-R between screening and baseline).

  • Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:

    • Neurodevelopmental disorders
    • Schizophrenia spectrum and other psychotic disorders
    • Bipolar and related disorders
    • Trauma and stressor-related disorders
    • Disruptive · Impulse Control · and Conduct disorders

  • Have a current diagnosis (DSM-5) of the following as judged by the investigator:

    • Obsessive-compulsive and related disorders
    • Anorexia nervosa, Bulimia nervosa, Binge-eating disorder
    • Sleep-wake disorders
    • Neurocognitive disorders
    • Disruptive mood dysregulation disorder
  • Have personality disorders, in the judgement of the investigator.
Contacts and Locations
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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): NCT03315793


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Kobe, Hyogo, Japan, 651-0086
Sponsors and Collaborators
Eli Lilly and Company
Shionogi
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03315793     History of Changes
Other Study ID Numbers: 14937
F1J-JE-B058 ( Other Identifier: Eli Lilly and Company )
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents