A phase 3 study of S-812217 in patients with major depressive disorder
- Conditions
- depression
- Registration Number
- JPRN-jRCT2031210577
- Lead Sponsor
- agata Tsutae
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Patients who have been interviewed using Mini-International Neuropsychiatric Interview (M.I.N.I.) and had diagnosis of depression according to the DSM-5, and who meet the following 2 conditions:
> The current episode is ongoing for at least 8 weeks prior to the day of signing the ICF.
> Duration of current episode is 12 months or less prior to signing the ICF.
Patients with treatment-resistant depression; no improvement in depressive symptoms even though at least two different antidepressants, except for antipsychotics, have been administered for treatment of an existing depressive episode at adequate doses approved in the countries for 4 weeks. The Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) will be evaluated only at Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baselinea in HAM-D17 total score on Day 15 of Part A
- Secondary Outcome Measures
Name Time Method