jRCT2022210028进行中（未招募）不适用
An Exploratory Study of FHM-001 in Patients with Depression/Multicenter, parallel-group study
DT-Axis Co.,Ltd.0 个研究点目标入组 143 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 143
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 65age old not（—）
- 性别
- All
入选标准
- •(1)Japanese patients aged 18 to less than 65 years who provided appropriate written informed consent
- •(2)Ongoing episodes with primary diagnosis of non-psychotic depression (DSM -5)
- •(3)A total score of > 10 on the PHQ -9 scale and a total score of > 17 on the HAM-D (17 items) scale by the central assessment.
- •(4)Subject must have a Clinical Global Impression of Change (CGI-I) score of > 3 (mild improvement) and no response or partial response, in the opinion of the investigator, to any single standard of care antidepressant [Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin and Noradrenaline Reuptake Inhibitors (SNRI), Noradrenergic and Specific Serotonergic Antidepressants (NaSSA)] after at least 4 weeks of stable treatment.
- •(5)Patients who have been taking one of the antidepressants used as standard of care drugs (SSRIs, SNRIs, NaSSAs) at a fixed dosage and administration for 4 weeks or longer and who are judged by the investigator/subinvestigator to have no problem with tolerability and to be able to continue the treatment without changing the dosage and administration
排除标准
- •(1) Patients with previous or current schizophrenia or other psychotic disorders, or bipolar disorder or other related disorders, based on the diagnostic criteria in the DSM-5
- •(2) Patients with any of the following disorders based on the diagnostic criteria in the DSM-5: Delirium, dementia, substance-related disorder, borderline personality disorder, eating disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, intellectual disability, and autistic spectrum disorder
- •(3) Patients with a significant risk of suicide who have had suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) type 4 or 5 within the past 3 months or committed suicidal behavior within 1 year prior to the start of the screening period
- •(4) Patients under hospitalization, or patients scheduled to be hospitalized for the treatment of a physical disorder or depression during the study period
- •(5) Patients who have received systematic individual psychotherapy (cognitive behavioral therapy [CBT], interpersonal therapy, dynamic psychotherapy, problem-solving therapy, psychoanalytic therapy, etc.) for the episode concerned
- •(6) Patients who have received electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) for the episode concerned
- •(7) Patients who cannot use antidepressants (SSRI, SNRI, or NaSSA) specified as the standard treatments
- •(8) Patients with a history of diagnosis or treatment of malignancy within 5 years before the start of the screening period, or patients with current malignancy
- •(9) Female patients who are pregnant, breastfeeding, or may be pregnant
- •(10) Male patients and female patients of childbearing potential who do not agree to practice contraception during the study period
- •(11) Patients who have participated in a clinical study of a CBT application and used the CBT application
结局指标
主要结局
-
HAM-D (17 items) total score (change from baseline at Week 8)
次要结局
未报告次要终点
研究者
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