Berberine Improving Cognitive Impairments in Schizophrenia

Tianjin Anding Hospital

Status

Invitation-only

Conditions

Schizophrenia Therapeutics

Treatments

Drug: Berberine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07359209

BBR-SCH-2023

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.