A phase 2 study of S-812217 in patients with major depressive disorder
- Conditions
- Major depressive disorder
- Registration Number
- JPRN-jRCT2080225180
- Lead Sponsor
- SHIONOGI & CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 240
Patients who have been interviewed using Mini-International Neuropsychiatric. Interview (M.I.N.I) and diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) and met the following 2 conditions:
- The current episode is ongoing for at least 8 weeks prior to the day of signing the informed consent form
- Duration of current episode is <= 12 months prior to signing the informed consent
, etc.
- Patients with treatment-resistant depression (defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants [excluding antipsychotics] within the current depressive episode from two or more different classes for at least 4 weeks of treatment). (The Massachusetts General Hospital Antidepressant Treatment Response Questionnaire [MGH ATRQ] will be used for the evaluation)
- Patients who have been treated with devices such as vagal nerve stimulation, electroconvulsive therapy, and transcranial magnetic stimulation within the current depressive episode.
, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method