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

ID: NCT03395353
Status: Recruiting
Phase: Phase 3
Start Date: January 29, 2018
First Submitted: January 04, 2018
Last Updated: February 22, 2018
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company, Shionogi
Location: Japan
Conditions: Depressive Disorder
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Depressive Disorder

Drug: Duloxetine Hydrochloride
Other Names
LY248686
Phase 3

Tracking Information

First Submitted DateJanuary 04, 2018
Last Update Posted DateFebruary 22, 2018
Actual Start DateJanuary 29, 2018
Anticipated Completion DateMarch 31, 2021
Actual Primary Completion DateMarch 31, 2021
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Percentage of Participants with Any Adverse Events (AEs) [Time Frame: Baseline through Week 52]

    Percentage of participants with any AEs

  • Percentage of Participants with Any Adverse Reactions (ADRs) [Time Frame: Baseline through Week 52]

    Percentage of participants with any ADRs

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

    Percentage of participants with any SAEs

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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

  • 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

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

    PK: Trough Concentration of Duloxetine

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Official TitleA Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
100
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Depressive Disorder
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Duloxetine Hydrochloride

Administered orally

Other Names
LY248686
Study Groups/Cohorts
Duloxetine hydrochloride
Duloxetine hydrochloride administered orally.

Study Arms
Experimental Duloxetine hydrochloride
Duloxetine hydrochloride administered orally.
Drug : Duloxetine Hydrochloride
Administered orally

Arm Intervention/Treatment
Experimental Duloxetine hydrochloride
Duloxetine hydrochloride administered orally.
Drug : Duloxetine Hydrochloride

Recruitment Information

Recruitment Status:Recruiting
Enrollment100
Completion DateMarch 31, 2021
Eligibility 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.
GenderAll
Age9 Years to 17 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Japan

Administrative Information

NCT Number:NCT03395353
Other Study ID Numbers
16916
F1J-JE-HMHF
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
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