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

Tianjin Anding Hospital65 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia Therapeutics

Eligibility

Sex: ALLMin age: 18 YearsMax age: 62 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: changes within 0,4,8weeks

Secondary Outcomes

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

Time frame: changes within 0,4,8 weeks

Changes of Insulin

The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks

Time frame: changes within 0,4,8 weeks

Changes of TC

The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks

Time frame: changes within 0,4,8 weeks

Changes of TG

The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks

Time frame: 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

Time frame: 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

Time frame: changes within 0,4,8weeks

Safety

Evaluate the safety of berberine

Time frame: changes within 0,4,8weeks

Changes of CRP

The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: changes within 0,4,8weeks

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes