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A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With 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: NCT03395353
Recruitment Status : Active, not recruiting
First Posted : January 10, 2018
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Brief Summary:
The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : July 3, 2020
Estimated Study Completion Date : July 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duloxetine hydrochloride
Duloxetine hydrochloride administered orally.
Drug: Duloxetine Hydrochloride
Administered orally
Other Name: LY248686




Primary Outcome Measures :
  1. Percentage of Participants with Any Adverse Events (AEs) [ Time Frame: Baseline through Week 52 ]
    Percentage of participants with any AEs

  2. Percentage of Participants with Any Adverse Reactions (ADRs) [ Time Frame: Baseline through Week 52 ]
    Percentage of participants with any ADRs

  3. Percentage of Participants with Any Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 52 ]
    Percentage of participants with any SAEs


Secondary Outcome Measures :
  1. Change from Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Baseline, Week 52 ]
    Change from baseline on the CDRS-R

  2. Change from Baseline on the Clinical Global Impression-Severity of Illness (CGI-S) [ Time Frame: Baseline, Week 52 ]
    Change from baseline on the CGI-S

  3. Pharmacokinetics (PK): Trough Concentration of Duloxetine [ Time Frame: Week 4 through Week 50 ]
    PK: Trough Concentration of Duloxetine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • a) Participants extended from B058(1701A3631) study.
  • b) New participants.

Inclusion Criteria

  • a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and give signed informed consent to continue duloxetine administration in this study.
  • b) 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.
  • b) Participants whose incipient age of depression was ≥7 years old.

Exclusion Criteria:

  • a, b) 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
  • a, b) 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
  • a, b) Have personality disorders, in the judgment of 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): NCT03395353


Locations
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Japan
Shionogi
Osaka, Japan, 541-0045
Sponsors and Collaborators
Shionogi
Eli Lilly and Company
Investigators
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Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
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Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT03395353    
Other Study ID Numbers: 16916
F1J-JE-HMHF ( Other Identifier: Eli Lilly and Company )
1702A3632 ( Other Identifier: Shionogi )
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Depressive Disorder
Depression
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