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

ID: NCT03315793
Status: Recruiting
Phase: Phase 3
Start Date: December 04, 2017
First Submitted: October 17, 2017
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 study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.

Detailed Description

Condition or disease Intervention/treatment Phase

Depressive Disorder

Drug: Duloxetine Hydrochloride
Other Names
LY248686
Drug: Placebo
Other Names
Phase 3

Tracking Information

First Submitted DateOctober 17, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateDecember 04, 2017
Anticipated Completion DateFebruary 04, 2020
Actual Primary Completion DateFebruary 04, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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

  • 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

  • Percentage of Participants with Total CDRS-R Score ≤ 28 [Time Frame: Week 6]

    Percentage of participants with total CDRS-R score ≤ 28

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

    Mean change from baseline on CGI-S

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
Official TitleA Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
148
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
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
Drug: Placebo

Administered orally

Other Names
Study Groups/Cohorts
Duloxetine Hydrochloride
Duloxetine hydrochloride given orally.

Placebo
Placebo given orally.

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

Placebo Comparator Placebo
Placebo given orally.
Drug : Placebo
Administered orally

Arm Intervention/Treatment
Experimental Duloxetine Hydrochloride
Duloxetine hydrochloride given orally.
Drug : Duloxetine Hydrochloride
Placebo Comparator Placebo
Placebo given orally.
Drug : Placebo

Recruitment Information

Recruitment Status:Recruiting
Enrollment148
Completion DateFebruary 04, 2020
Eligibility 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.
GenderAll
Age9 Years to 17 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Japan

Administrative Information

NCT Number:NCT03315793
Other Study ID Numbers
14937
F1J-JE-B058
Has Data Monitoring CommitteeYes
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