The study was a 12-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg, three times a day) has been used as an auxiliary treatment on the basis of stable antipsychotic treatment. All participants were randomly divided into two groups.Any stable antipsychotic + berberine(BBR) or any stable antipsychotic +placebo. Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms. MATRICS Consensus Cognitive Battery（MCCB）has been used for cognitive symptoms. The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects. Plasma Metabolomics, Inflammatory Factors, BDNF, fecal Macrogene Sequencing, and fecal Metabolomics were obtained at 0, 4,8 ,12weeks.
Plasma Metabolomics, Inflammatory Factors, BDNF, fecal Macrogene Sequencing, and fecal Metabolomics were obtained at 0, 4,8 ,12weeks. Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Berberine 300mg#three times a day# plus any stable antipsychotic drug
The placebo were matched to Berberine in shape, smell and colour and tablets were sealed in identical bottles
Tianjin Anding Hospital
Tianjin, China
Changes of cogination symptoms
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.
Time frame: changes within 0,4,8,12weeks
Changes of CRP
The concentration of C-reactive protein (CRP) is measured in venous blood. CRP is an acute-phase reactant protein synthesized by the liver, primarily functioning to recognize and clear pathogens or damaged cells. It plays a crucial role in inflammatory responses, infection surveillance, and disease monitoring.
Time frame: changes within 0, 4, 8, 12weeks
Changes of Plasma Metabolomics(PM)
Collected and stored plasma samples were registered in the MetLIMS software, including relevant sample information. Subsequently, these samples underwent mass spectrometry-based detection and quantification. Each sample was divided into two aliquots for analysis: the first aliquot was subjected to Flow Injection Analysis (FIA) mode for signal acquisition, and the second aliquot was analyzed using Liquid Chromatography-Mass Spectrometry (LC-MS) mode. The resultant data were imported into the Biocrates MetIDQ™ software for the precise calculation of analyte concentrations and comprehensive data evaluation. Further analysis was conducted utilizing the MetaboAnalyst 5.0 platform, along with resources such as the KEGG database, to identify significant metabolites and explore associated metabolic pathways.
Time frame: changes within 0, 12weeks
Changes of IL-1β
The levels of IL-1β has been obtained at 4 point intervals: 0, 4, 8,12 weeks
Time frame: changes within 0,4,8,12weeks
Changes of IL-6
The levels of IL-6 has been obtained at 4 point intervals: 0, 4, 8 ,12weeks
Time frame: changes within 0,4,8,12weeks
Changes of TNF-α
The levels of TNF-α has been obtained at 4 point intervals: 0, 4, 8 ,12weeks
Time frame: changes within 0,4,8,12weeks
Changes of BDNF
The levels of BDNF has been obtained at 4 point intervals: 0, 4, 8,12 weeks
Time frame: changes within 0,4,8,12weeks
Changes of Fecal Macrogene Sequencing(FMS)
Total genomic DNA was extracted from patient fecal samples and subjected to quality control. Qualified DNA was then randomly fragmented to approximately 350 bp using a Covaris ultrasonic disruptor to generate libraries, which were quantified by Qubit and qPCR. Following library QC, pooled libraries were sequenced on an Illumina NovaSeq platform (PE150). Raw sequencing data underwent quality control, followed by assembly and gene prediction to construct a non-redundant gene set. Genes were then annotated for taxonomic and functional classification and abundance statistics were computed. Statistical analyses, including similarity clustering, group ordination, and differential comparisons, were performed on samples and sample groups.
Time frame: changes within 0, 12weeks
Changes of Fecal Metabolomics(FM)
Collected and stored patient fecal samples were registered in the MetLIMS software, including relevant sample information. Subsequently, these samples underwent mass spectrometry-based detection and quantification. Each sample was divided into two aliquots for analysis: the first aliquot was subjected to Flow Injection Analysis (FIA) mode for signal acquisition, and the second aliquot was analyzed using Liquid Chromatography-Mass Spectrometry (LC-MS) mode. Data Processing and Pathway Analysis: The resultant data were imported into the Biocrates MetIDQ™ software for the precise calculation of analyte concentrations and comprehensive data evaluation. Further analysis was conducted utilizing the MetaboAnalyst 5.0 platform, along with resources such as the KEGG database, to identify significant metabolites and explore associated metabolic pathways.
Time frame: changes within 0, 12weeks
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