NCT04486092Unknown不适用
Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Gut microbiota composition
研究概览
简要总结
The potential effects of microbiota in bipolar disorder (BD) with microbiota-related dysfunction have not yet been explored clinically, and the integration of microbiota and pharmacometabolomic approaches can provide us the identification of the significant effects of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance. Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Bipolar disorder outpatients (aged 18-65 years) who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria and start to receive valproate (VPA) will be enrolled consecutively by trained psychiatrists.
排除标准
- •Exclude are patients who had DSM-V diagnosis for substance abuse within the past three months
- •Had treated with antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month before entering study
- •Presence of stomach/gut problems such as chronic diarrhea, constipation, gas, heartburn, bloating, etc.
- •Had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
- •Had a surgical condition or a major physical illness
- •Were pregnant or breast-feeding
- •Had any concomitant DSM-V Axis I diagnoses together with somatic or neurologic illnesses interfering psychiatric evaluation.
研究组 & 干预措施
Valproic Acid
Experimental
干预措施: Valproic Acid (Drug)
结局指标
主要结局
Gut microbiota composition
时间窗: 12 weeks
次要结局
- Metabolic syndrome(12 weeks)
研究者
研究点 (1)
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