Back to resultsA Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Primary Purpose
Depressive Disorder
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
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.
Sites / Locations
- Shionogi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Duloxetine hydrochloride
Arm Description
Duloxetine hydrochloride administered orally.
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study.
Secondary Outcome Measures
Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)
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 higher 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.
Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Pharmacokinetics (PK): Trough Concentration of Duloxetine
Trough concentrations of duloxetine are defined as the plasma concentrations in 18 - 30 hours post the previous dose. PK samples were obtained from each subject from Week 4 to the end of treatment period (Week 50) for analysis of steady state duloxetine concentrations. If duloxetine dose changed, PK samples were taken after 2 week or more administration of the new dose. Principally 1 or 2 blood samples were drawn from each subject at pre-dose for trough concentrations.
Full Information
NCT ID
NCT03395353
First Posted
January 4, 2018
Last Updated
May 25, 2021
Sponsor
Shionogi
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03395353
Brief Title
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Official Title
A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
July 4, 2020 (Actual)
Study Completion Date
July 4, 2020 (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
No
5. 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.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine hydrochloride
Arm Type
Experimental
Arm Description
Duloxetine hydrochloride administered orally.
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride
Other Intervention Name(s)
LY248686
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
Description
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study.
Time Frame
Baseline through Week 53
Secondary Outcome Measure Information:
Title
Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)
Description
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 higher 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 50
Title
Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)
Description
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Time Frame
Baseline, Week 50
Title
Pharmacokinetics (PK): Trough Concentration of Duloxetine
Description
Trough concentrations of duloxetine are defined as the plasma concentrations in 18 - 30 hours post the previous dose. PK samples were obtained from each subject from Week 4 to the end of treatment period (Week 50) for analysis of steady state duloxetine concentrations. If duloxetine dose changed, PK samples were taken after 2 week or more administration of the new dose. Principally 1 or 2 blood samples were drawn from each subject at pre-dose for trough concentrations.
Time Frame
Week 4 through Week 50
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shionogi Clinical Trials 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
Learn more about this trial
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
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