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

Phase 3

Terminated

Conditions: Depressive Disorder

Interventions: Drug: Duloxetine Hydrochloride

Registration Number: NCT03395353

Lead Sponsor: Shionogi

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: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 151

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duloxetine hydrochloride	Duloxetine Hydrochloride	Duloxetine hydrochloride administered orally.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)	Baseline through Week 53	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

Name	Time	Method
Pharmacokinetics (PK): Trough Concentration of Duloxetine	Week 4 through Week 50	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.
Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)	Baseline, Week 50	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).
Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)	Baseline, Week 50	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.