NCT03871088已完成不适用
N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
National Science and Technology Council, Taiwan2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression (HAMD) Changes
研究概览
简要总结
Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD.
详细描述
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the diagnostic criteria of DSM-IV for MDD
- •18 to 65 years old
- •pre-study ratings of 18 or greater on the 21-item Hamilton Rating Scale for Depression (HAMD)
- •physically healthy under comprehensive evaluations in medical history, physical examination, and laboratory parameters tests
- •have not received any psychiatric treatment in 2 weeks
- •competent to receive a full explanation of this study and give written informed consent.
排除标准
- •a recent or past history of other DSM-IV AxisI diagnoses besides unipolar major depression, including psychotic disorders, organic mental disorders, impulse control disorders, substance use disorder or substance abuse (last 6 months prior to the study), and bipolar disorders
- •AxisII diagnoses, including borderline and antisocial personality disorder
- •a notable medical comorbidity
- •acutely suicidal ideation and attempt were noted that close monitoring such as hospitalization is necessary
- •regular consumption of omega-3 PUFAs supplements or a habit of eating fish equal or more than 4 times per week
结局指标
主要结局
Hamilton Rating Scale for Depression (HAMD) Changes
时间窗: From Week 0 to Week 12
The Changes of scores in Hamilton Rating Scale for Depression
次要结局
- Response rate(at Week 12)
- Remission rate(at Week 12)
研究者
Kuan-Pin
Professor
National Science and Technology Council, Taiwan
研究点 (2)
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