Status:
TERMINATED
A Study of Duloxetine (LY248686) in the Treatment of 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 long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2020
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03395353
Start Date
January 29 2018
End Date
July 4 2020
Last Update
June 18 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shionogi
Osaka, Japan, 541-0045