Optimizing Mental Health Management With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The primary endpoint is the percent change in mental health scores (Hamilton Depression Rating Scale, Generalized Anxiety Disorder 7-item scale) for the AI-Guided group compared with the Control group.
研究概览
简要总结
The study "Optimizing Mental Health Management with AI-Guided (GenAIS TM) Dietary Supplementation" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing mental health disorders, specifically depression and anxiety. This 6-month randomized controlled trial included 160 participants diagnosed with major depressive disorder or generalized anxiety disorder. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in mental health scores, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Age between 18 and 65 years.
- •Diagnosed with major depressive disorder (MDD) or generalized anxiety disorder (GAD) according to DSM-5 criteria.
- •Moderate to severe symptoms as indicated by scores on HAM-D (≥17) for depression or GAD-7 (≥10) for anxiety.
- •Stable on psychiatric medication for at least 3 months prior to the study.
- •Willingness to provide genetic and metabolic data.
- •Written informed consent.
排除标准
- •Current or past history of severe psychiatric conditions such as schizophrenia, bipolar disorder, or other psychotic disorders.
- •Current substance abuse or dependence within the last 6 months.
- •Significant medical conditions like severe renal, hepatic, or cardiovascular diseases.
- •Pregnancy or breastfeeding.
- •Recent changes in psychiatric medication within the last 3 months.
- •Participation in another clinical trial within the last 30 days.
结局指标
主要结局
The primary endpoint is the percent change in mental health scores (Hamilton Depression Rating Scale, Generalized Anxiety Disorder 7-item scale) for the AI-Guided group compared with the Control group.
时间窗: 6 months
The Hamilton Depression Rating Scale is a clinician-administered assessment used to measure the severity of depression in individuals. It consists of 17 to 21 items, with each item scored on a scale of 0 to 4 or 0 to 2. The Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-administered questionnaire used to screen for and measure the severity of generalized anxiety disorder. It consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day), with the total score ranging from 0 to 21. Higher scores indicate greater anxiety severity.
次要结局
- Changes in quality of life score Short Form Health Survey(6 months)
- Percent change in specific symptoms of depression and anxiety.(6 months)
- Percent change in high-sensitivity C-reactive protein(6 months)
- Percent change in body weight and body mass index(6 months)
- Incidence of adverse effects related to dietary supplements.(6 months)
- Number of Participant adherence to the prescribed dietary supplements regimen.(6 months)
- Changes in quality of life score World Health Organization Quality of Life(6 months)