A clinical trial of MLD-55 in pediatric patients with depressio
Phase 3
Completed
- Conditions
- Major depressive disorder
- Registration Number
- JPRN-jRCT2080224520
- Lead Sponsor
- Mochida Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Patients with a primary diagnosis of major depressive disorder or persistent depressive disorder completely meeting the criteria of major depressive episode throughout the preceding 1 year according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Exclusion Criteria
(1)Patients with a complication or history of any of the following DSM-5-classified diseases:
- Bipolar and related disorders
- Schizophrenia spectrum and other psychotic disorders
(2)Patients with a history of suicidal behavior (suicide attempt, interrupted suicide attempts) based on C-SSRS within one year prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method