Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients

Study Overview
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Brief Summary
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The etiology and pathogenesis of schizophrenia remains unclear. Immune dysfunction hypothesis for schizophrenia has attracted increasing attention of the researchers, substantial evidences suggested the levels of C-reaction protein and cytokine such as IL-1β, IL-6, TNF-α markedly elevated in patients with schizophrenia which may be particularly relevant for the cognitive impairment and metabolic disturbance of schizophrenia. In recent years, it has been demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism, reducing the proinflammatory status and improving cognition. As the investigators known, the report of berberine being used in schizophrenia is rare. This protocol is aim to evaluate berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism, cognition in patients with schizophrenia.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Berberine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who age 18 to 60 years diagnose schizophrenia according the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID). The patients have illness for less than 5 years and have stable dose of the current antipsychotic drug for at least one month. Well established compliance with inpatient treatment per treating clinician's judgment. On baseline, at least 60 for Positive and Negative Syndrome Scale (PANSS) total score. Able to complete the cognitive assessment battery Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study. Exclusion Criteria: Individuals who refuse to provide informed consent. Currently substance abuse or psychiatrically unstable per treating clinician's judgment. One with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial. 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 pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berberine group<br>Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy. | Drug: Berberine<br>* Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.<br>* Other names: Rhizoma coptidis;|
| Placebo Comparator: Placebo group<br>Accept placebo(300 mg/tid)+SGAs monotherapy. | Drug: Placebo<br>* Accept placebo(300 mg/tid)+SGAs monotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of glucose |  | Change from Baseline Glucose at 12 weeks | 
| The change of insulin |  | Change from Baseline insulin at 12 weeks | 
| The change of HbA1c |  | Change from Baseline HbA1c at 12 weeks | 
| The change of lipid profile |  | Change from Baseline lipid profile at 12 weeks | 
| The change of CRP |  | Change from Baseline CRP at 12 weeks | 
| The change of IL-1β |  | Change from Baseline IL-1β at 12 weeks | 
| The change of IL-6 |  | Change from Baseline IL-6 at 12 weeks | 
| The change of TNF-α |  | Change from Baseline TNF-α at 12 weeks | 
| The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB) | The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function | Change from Baseline Cognitive function at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale | The Positive and Negative Syndrome Scale for clinical symptoms | Change from Baseline clinical symptoms at 12 weeks | 
| Adverse event |  | At 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRP, Berberine, Cytokine, Metabolism, Schizophrenia