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

NCT03395353 | Terminated Phase 3 Results FDA Drug

• 3 other identifiers: 16916F1J-JE-HMHF1702A3632
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)

  Baseline, Week 50

• Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)

  Baseline, Week 50

• Pharmacokinetics (PK): Trough Concentration of Duloxetine

  Week 4 through Week 50

Study Arms (1)

Duloxetine hydrochloride

EXPERIMENTAL

Duloxetine hydrochloride administered orally.

Drug: Duloxetine Hydrochloride

Interventions

Duloxetine Hydrochloride DRUG

Administered orally

Also known as: LY248686

Duloxetine hydrochloride

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Shionogi

Osaka, 541-0045, Japan

Location

Related Publications (1)

• Shibata RY, Kubota R, Uenaka K, Kaibara A, Wajima T. Population pharmacokinetics of duloxetine in Japanese pediatric patients with major depressive disorder. Drug Metab Pharmacokinet. 2023 Aug;51:100496. doi: 10.1016/j.dmpk.2023.100496. Epub 2023 Feb 15.

  PMID: 37244205 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Corporate Communications Department
• Organization: Shionogi

shionogiclintrials-admin@shionogi.co.jp

+81-6-6209-7885

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 10, 2018
• Study Start: January 29, 2018
• Primary Completion: July 4, 2020
• Study Completion: July 4, 2020
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)