Study on the Mechanism s of Berberine Improving Cognitive Impairments in Schizophrenia Based on Gut-brain Axis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in the MCCB Overall Composite Score
研究概览
简要总结
This study is a 12-week, randomized, blank-controlled, assessor-blinded trial. Eligible patients were randomized in a 1:1 ratio to receive either berberine hydrochloride or blank control as an add on to their stable antipsychotic regimen for 12 weeks. Randomization was performed using a computer-generated random number table, and allocation was concealed using sequentially numbered, opaque, sealed envelopes. The trial included four visits: baseline (visit 1), week 4 (visit 2), week 8 (visit 3) and week 12 (visit 4). Patients in the berberine group received berberine hydrochloride tablets (100 mg/tablet), three tablets three times daily. The control group received no intervention (blank control) and continued their usual care.
详细描述
Psychiatric symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS); cognitive symptoms were evaluated using the MATRICS Consensus Cognitive Battery (MCCB); depressive symptoms were assessed using the 24-item Hamilton Depression Rating Scale (HAMD-24); and anxiety symptoms were evaluated using the Hamilton Anxiety Rating Scale (HAMA). All assessments were administered by trained research personnel. The MCCB assessment was performed only at baseline and Week 12, whereas the PANSS, HAMD, and HAMA assessments were conducted at baseline, Week 4, Week 8, and Week 12. The primary outcome measure was the uncorrected T-score of the MCCB Overall Composite Score, which was derived by standardizing and summing the T-scores across seven cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Since commercially available berberine is only formulated as yellow tablets with a marked bitter taste, which makes it difficult to prepare an indistinguishable placebo, a blank control design was adopted to maintain feasibility while ensuring the integrity of the study. We acknowledge that this open-label design may introduce potential placebo effects. Nevertheless, the cognitive assessments are less susceptible to expectancy effects, and both the raters and statisticians were blinded to group assignment to minimize bias.
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
- 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
- •a diagnosis of SCZ according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- •receiving stable doses of antipsychotic medication for at least 1 month before enrollment;
- •age between 18 and 65 years;
- •provision of written informed consent by patients and their families.
排除标准
- •a current diagnosis of any other DSM-5 psychiatric disorder;
- •presence of severe physical illness;
- •receipt of physical treatments such as repetitive transcranial magnetic stimulation or modified electroconvulsive therapy within one month prior to enrollment;
- •hemolytic anemia or glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- •pregnant and lactating women;
- •any factor that would interfere with the participant's ability to provide informed consent or complete the study.
研究组 & 干预措施
control group
berberine group
干预措施: Berberine (Drug)
结局指标
主要结局
Change in the MCCB Overall Composite Score
时间窗: changes within 0, 12weeks
MCCB is a standardized measurement tool for assessing cognitive function in schizophrenia. There are 9 subtests, which mainly assess 7 cognitive domains, including information processing speed, attention/alertness, Working memory, word learning, visual memory, reasoning and problem solving, and social cognition. After the evaluation is completed, the MCCB rough score is converted into the total score T score obtained after correction for age, gender, years of education, and untreated period. The T score is then converted into a defect score, with T scores ≥ 40, 35-39, 30-34, 25-29, 20-24, and ≤ 19 corresponding to defect scores 0, 1, 2, 3, 4, and 5, respectively. Among them, 1 represents mild defects, 2 represents mild to moderate defects, 3 represents moderate defects, 4 represents moderate to severe defects, and 5 represents severe defects. In this study, a defect score of ≥ 3 was used as the boundary for significant cognitive impairment.
次要结局
- Change from baseline in scores on the remaining MCCB domains(changes within 0, 12weeks)
- Psychiatric Symptoms(changes within 0, 4, 8,12weeks)
- Depressive Symptoms(changes within 0, 4, 8,12weeks)
- Anxiety Symptoms(changes within 0, 4, 8, 12weeks)
- Changes of Fecal Macrogene Sequencing(FMS)(changes within 0, 12weeks)
- Changes in plasma levels of short-chain fatty acids.(changes within 0, 12weeks)
- Changes in plasma bile acid levels(changes within 0, 12weeks)
- Changes in plasma tryptophan levels(changes within 0, 12weeks)
- Changes of CRP(changes within 0, 4, 8, 12weeks)
- Changes in glycolipid levels(Baseline, week 4, week 8 and week 12)
- Weight changes(Baseline, week4, week8, week12)