Study on the Mechanism s of Berberine Improving Cognitive Impairments in Schizophrenia Based on "Gut m Icrobiota-gut-brain"Axis
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Tianjin Anding Hospital
- Enrollment
- 100
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.