A phase 3 study of S-812217 in patients with major depressive disorder

A phase 3 study of S-812217 in patients with major depressive disorder consisting of randomized, double-blind, placebo-control part and extension, open-label, re-treatment part

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210577

Enrollment

400

Registered

2022-01-23

Start date

2022-01-23

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

depression

Interventions

Part A: S-812217 or Placebo oral administration Part B: S-812217 oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Change from baselinea in HAM-D17 total score on Day 15 of Part A	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026