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

JRCT ID: jRCT2031220423

Registered date:28/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: depression
• Date of first enrollment: 01/11/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 administration in combination with an antidepressant

Outcome(s)

• Primary Outcome: Presence or absence of HAM-D17 response (HAM-D17 total score decreased by 50% or more from baseline) on Day 15 of Part A

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 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).

• Exclude 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.

Related Information

• Primary Sponsor: Gomez Juan Carlos