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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225180

Enrollment

240

Registered

2020-04-28

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

investigational material(s) Generic name etc : S-812217 INN of investigational material : Zuranolone Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 29, 2026