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A phase 2 study of S-812217 in patients with major depressive disorder

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Major depressive disorder
Date of first enrollment	28/04/2020
Target sample size	240
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : S-812217 INN of investigational material : Zuranolone Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

efficacy Changes from the baseline to Visit 4 in the total score of Hamilton Rating Scale for Depression, 17-item version (HAM-D17).

Secondary Outcome

safety efficacy Efficacy: - Clinical Global Impression - Global Improvement (CGI-I) score and the presence or absence of its improvement - Clinical Global Impression -Severity of Illness (CGI-S) score and the presence or absence of normal/borderline mentally ill - Patient Global Impression of Improvement (PGI-I) score and the presence or absence of its improvement - Patient Health Questionnaire -9 (PHQ-9) score and its change from the baseline - Short Form Health Survey (SF-36) subscales and summary score as well as its change from the baseline - Insomnia Severity Index (ISI) total score and its change from the baseline , etc. Safety: - Incidence of adverse events/adverse reactions

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 75age old
Gender	Both
Include criteria	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.
Exclude criteria	- 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.