Status:
COMPLETED
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
Lead Sponsor:
Shionogi
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Depressive Disorder
Eligibility:
All Genders
9-17 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2019
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT03315793
Start Date
December 4 2017
End Date
November 8 2019
Last Update
January 5 2021
Active Locations (1)
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1
Shionogi
Osaka, Japan, 541-0045