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

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
Placebo
Sponsored by
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shionogi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duloxetine Hydrochloride

Placebo

Arm Description

Duloxetine hydrochloride given orally.

Placebo given orally.

Outcomes

Primary Outcome Measures

Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates.

Secondary Outcome Measures

Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline
The Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression.
Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline
The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning with higher numbers indicating a greater degree of depression . The total sum of scores range from 17 to 113. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression.
Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28
The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Remission was defined for the CDRS-R total score below 28.
Change From Baseline on Clinical Global Impression-Severity (CGI-S)
CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Presented here are the LS mean change from baseline on CGI-S calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CGI-S and age as covariates.

Full Information

First Posted
October 17, 2017
Last Updated
December 8, 2020
Sponsor
Shionogi
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03315793
Brief Title
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1, 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi
Collaborators
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine Hydrochloride
Arm Type
Experimental
Arm Description
Duloxetine hydrochloride given orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given orally.
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride
Other Intervention Name(s)
LY248686
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Description
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline
Description
The Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression.
Time Frame
Baseline, Week 6
Title
Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline
Description
The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning with higher numbers indicating a greater degree of depression . The total sum of scores range from 17 to 113. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression.
Time Frame
Baseline, Week 6
Title
Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28
Description
The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Remission was defined for the CDRS-R total score below 28.
Time Frame
Baseline, Week 6
Title
Change From Baseline on Clinical Global Impression-Severity (CGI-S)
Description
CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Presented here are the LS mean change from baseline on CGI-S calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CGI-S and age as covariates.
Time Frame
Baseline, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shionogi Clinical Trial Administrator Clinical Support Help Line
Organizational Affiliation
Shionogi
Official's Role
Study Director
Facility Information:
Facility Name
Shionogi
City
Osaka
ZIP/Postal Code
541-0045
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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