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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder
• Intervention / Treatment: Drug: Duloxetine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 541-0045
    • Shionogi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Duloxetine hydrochloride; Duloxetine hydrochloride administered orally.	Drug: Duloxetine Hydrochloride; Administered orally; Other Names: LY248686

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shionogi
• Collaborators: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2018
• Primary Completion (ACTUAL): July 4, 2020
• Study Completion (ACTUAL): July 4, 2020

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: 16916; F1J-JE-HMHF (OTHER: Eli Lilly and Company); 1702A3632 (OTHER: Shionogi)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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