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

A phase 3 study of S-812217 in combination with an antidepressant 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-jRCT2031220423

Enrollment

100

Registered

2022-10-28

Start date

2022-11-01

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 (randomized, double-blind, placebo-control part): S-812217 or Placebo oral administration in combination with an antidepressant Part B (extension, open-label, re-treatment part): S-812217 oral

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 prior to signing the ICF Patients who are taking one antidepressant (SSRI, SNRI, serotonin reuptake inhibitor/serotonin receptor modulator) within the approved dosage for at least 4 weeks before Day 1 (no change in dosage).

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 Day 1.

Design outcomes

Primary

Measure	Time frame
Presence or absence of HAM-D17 response (HAM-D17 total score decreased by 50% or more from baseline) 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