Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

Study Overview
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Brief Summary
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The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.

Detailed Description
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Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin, Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) . Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).

Official Title
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Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study

Conditions
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Schizophrenia, Therapeutics

Intervention / Treatment
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* Drug: Berberine
* Drug: atypical antipsychotic
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who aged 18 to 65 years Meet the diagnosis of schizophrenia according to DSM-IV Monotherapy of atypical antipsychotics for 4 weeks or more At least 60 for Positive and Negative Syndrome Scale (PANSS) Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential Sign the informed consent form Exclusion Criteria: Individuals who with diagnosis of other psychiatric disorders except schizophrenia according to DSM-IV 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 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> | Drug: Berberine<br>* Berberine 300mg（three times a day） plus any atypical antipsychotic drug<br>Drug: atypical antipsychotic<br>* Any atypical antipsychotic drug as the basic treatment<br>|
| Placebo Comparator: control group<br> | Drug: atypical antipsychotic<br>* Any atypical antipsychotic drug as the basic treatment<br>Drug: placebo<br>* The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of negative symptoms | Positive and Negative Syndrome Scale（PANSS）has been used to assess symptom severity in schizophrenia.Of the items included in PANSS ,seven constitute a Positive scale,seven form a Negative scale and sixteen constitute a General Psychopathology scale.7-point rating instrument was conceived.A total Score is computed three subscales.Minimum scores is 30 and maximum scores is 210.The higher score are considered the psychiatric symptoms more serious. | changes within 0,4,8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Fasting blood samples for Fasting blood glucose(FBG) | The levels of FBG has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8 weeks | 
| Changes of Insulin | The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8 weeks | 
| Changes of TC | The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8 weeks | 
| Changes of TG | The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks | 
| Changes of HDL-C | The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks | 
| Changes of LDL-C | The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks | 
| Safety | Evaluate the safety of berberine | changes within 0,4,8weeks | 
| Changes of CRP | The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks | 
| Changes of IL-1β | The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks | 
| Changes of IL-6 | The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks | 
| Changes of TNF-α | The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia；berberine；symptoms；inflammation