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

Study Overview
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Brief Summary
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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.

Official Title
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A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: Duloxetine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine hydrochloride<br>Duloxetine hydrochloride administered orally. | Drug: Duloxetine Hydrochloride<br>* Administered orally<br>* Other names: LY248686;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Week 53 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 50 | 
| 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). | Baseline, Week 50 | 
| 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. | Week 4 through Week 50 |