An open-label extension study of duloxetine in children and adolescents with depressive disorder
Phase 3
Completed
- Conditions
- Depressive disorder
- Registration Number
- JPRN-jRCT2080223797
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
Consecutive Participants:
Patients who have completed the 7-week treatment in the preceding study (A phase 3 clinical trial of duloxetine in children and adolescents with depressive disorder)
New Participants:
Patients who diagnosed with major depressive disorder or persistent depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and completely meet the criteria of major depressive episode. And et al.
Exclusion Criteria
Patients who have allergies to two or more medicines or have a history of severe allergic reactions with medicines. And et al.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>The incidence of both adverse events and adverse drug reactions
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) total score. And et al.