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

NCT03315793 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 14937F1J-JE-B0581701A3631
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. 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 a higher number indicates a greater 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. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates.

  Baseline, Week 6

Secondary Outcomes (4)

• Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline

  Baseline, Week 6

• Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline

  Baseline, Week 6

• Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28

  Baseline, Week 6

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

  Baseline, Week 6

Study Arms (2)

Duloxetine Hydrochloride

EXPERIMENTAL

Duloxetine hydrochloride given orally.

Drug: Duloxetine Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo given orally.

Drug: Placebo

Interventions

Duloxetine Hydrochloride DRUG

Administered orally

Also known as: LY248686

Duloxetine Hydrochloride

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Participants whose incipient age of depression was ≥7 years old.
• Total score of CDRS-R is ≥40 and CGI-S score is ≥4 at both screening and baseline.

You may not qualify if:

• Have remarkable response to psycho-education (defined as \>30% decrease in the total score of CDRS-R between screening and baseline).
• 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
• 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
• Have personality disorders, in the judgement of the investigator.

Sponsors & Collaborators

• Shionogi: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Shionogi

Osaka, 541-0045, Japan

Location

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: Shionogi Clinical Trial Administrator
• Organization: Shionogi

shionogiclinicaltrials-admin@shionogi.co.jp

+81-6-6209-7885

Study Officials

• Shionogi Clinical Trial Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 20, 2017
• Study Start: December 4, 2017
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)