A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Efficacy and Safety of Probiotics in Participants With Anxiety Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HAM-D-24)
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will enroll 60 individuals with mild-to-moderate anxiety depression. Following a 3-month intervention and a 1-month follow-up period, the study aims to: 1) evaluate the efficacy of probiotics by comparing anxiety, depression, and sleep scores to baseline; and 2) investigate the safety and underlying mechanisms by analyzing changes in serum biomarkers, gut microbiota, and related metabolites.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Age: 18-60 years old; Gender: male or female.
- •2) Meets the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for a mild-to-moderate depressive or anxiety symptoms.
- •3) Hamilton Depression Rating Scale (HAM-D-24) score ≥ 8 or Hamilton Anxiety Rating Scale (HAM-A-14) score ≥ 7 at screening.
- •4) Has no used of anxiolytic or antidepressant medications (including traditional Chinese patent medicines), with the exception of Escitalopram Oxalate, within 2 weeks prior to the first dose.
- •5) For participants of childbearing potential (male or female): Must agree to use least one medically approve form of contraception (e.g., intrautering device [IUD], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative urine pregnancy test at screening and must be non-lactating.
- •6) The participant is willing and be able to provide written informed consent to participate in the study.
排除标准
- •1) HAM-D-24 score ≥ 35 or HAM-A-14 score ≥
- •2) Presence of significant suicidal ideation.
- •3) History or current diagnosis of neuropsychiatric disorders such as schizophrenia or epilepsy.
- •4) History of head trauma (with loss of consciousness for >10 minutes), other unstable major somatic diseases, or any somatic condition that could cause psychiatric symptoms.
- •5) Suspected intellectual disability.
- •6) History of alcohol or substance abuse prior to enrollment.
- •7) Cranial magnetic resonance imaging (MRI) reveals organic lesions.
- •8) Participants who are deemed unsuitable for the study by the investigator for any other reason.
研究组 & 干预措施
Placebo + Escitalopram
干预措施: Placebo (Drug)
Probiotics + Escitalopram
干预措施: Probiotic (Drug)
Placebo + Escitalopram
干预措施: Escitalopram (Combination Product)
Probiotics + Escitalopram
干预措施: Escitalopram (Combination Product)
结局指标
主要结局
Hamilton Depression Rating Scale (HAM-D-24)
时间窗: Baseline, Day 30, Day 90, Day 120 (follow up)
Depression symptoms will be assessed using the 24-item Hamilton Depression Rating Scale (HAM-D-24) at baseline and the specified time points during the study. With higher scores indicating more severe depression, and scores categorized as \<8 non-depressed, 8-19 mild, 20-34 moderate, ≥35 severe for diagnosis and monitoring treatment response.
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: Baseline, Day 30, Day 90, Day 120 (follow up)
Anxiety symptoms will be evaluated using 14-item Hamilton Anxiety Rating Scales (HAM-A) at baseline and the specified time point during the study. Each item is scored on a scale of 0 (not present) to 4 (severe). The total score, calculated by summing all items, ranges from 0 to 56, with higher scores indicating greater anxiety severity, where 0-7 indicates no/minimal, 8-14 mild, 15-23 moderate and ≥24 severe.
次要结局
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline, Day 30, Day 90, Day 120 (follow up))
- Gastrointestinal Symptom Rating Scale (GSRS)(Baseline, Day 30, Day 90, Day 120 (follow up))