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 ofstable antipsychotic treatment. All participants were randomly divided into twogroups.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. Thetreatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects. PlasmaMetabolomics, Inflammatory Factors, BDNF, fecal Macrogene Sequencing, and fecalMetabolomics 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).
Drug: Berberine
Berberine 300mg#three times a day# plus any stable antipsychotic drug
Other Name: stable antipsychotic
Drug: Placebo
The placebo were matched to Berberine in shape, smell and colour and tablets were sealed
in identical bottles
Other Name: stable antipsychotic
Inclusion Criteria:
- Individuals who aged 18 to 60 years
- Meet the diagnosis of schizophrenia according to DSM-V
- Treatment with stable Antipsychotic ≥ 3 months, and the drug dose was not adjusted 1
month before enrollment
- The total score of the Positive and Negative Syndrome Scale (PANSS) ≤ 70 points,
with scores of item delusion, conceptual confusion, hallucination, and excitement ≤
4 points
- The MATRICS Conscience Cognitive Battery for Schizophrenia,MCCB) scoring defect
score ≥ 3 points
- Gender unlimited
- Sign the informed consent form
Exclusion Criteria:
- Individuals who with diagnosis of other psychiatric disorders except schizophrenia
according to DSM-V
- Refused to provide informed consent
- Significant medical illnesses including uncontrolled hypertension, diabetes, seizure
disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases
- Currently on anti-inflammatory or immunosuppressant medication including oral
steroids and history of chronic infection (including tuberculosis, HIV and
hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous
system demyelinating disorder, and any other known autoimmune or inflammatory
condition.
Tianjin Anding Hospital
Tianjin, China
Not Provided