JPRN-jRCT2031220423招募中3 期
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
Gomez Juan Carlos0 个研究点目标入组 100 人开始时间: 2022年10月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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.
研究者
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