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

Phase 3

Recruiting

• Conditions: depression

• Registration Number: JPRN-jRCT2031220423
• Lead Sponsor: Gomez Juan Carlos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified