Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Changes of negative symptoms
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
berberine group
干预措施: Berberine (Drug)
berberine group
干预措施: atypical antipsychotic (Drug)
control group
干预措施: atypical antipsychotic (Drug)
control group
干预措施: placebo (Drug)
结局指标
主要结局
Changes of negative symptoms
时间窗: changes within 0,4,8weeks
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.
次要结局
- Changes of HDL-C(changes within 0,4,8weeks)
- Changes of LDL-C(changes within 0,4,8weeks)
- Safety(changes within 0,4,8weeks)
- Changes of Fasting blood samples for Fasting blood glucose(FBG)(changes within 0,4,8 weeks)
- Changes of Insulin(changes within 0,4,8 weeks)
- Changes of TC(changes within 0,4,8 weeks)
- Changes of TG(changes within 0,4,8weeks)
- Changes of CRP(changes within 0,4,8weeks)
- Changes of IL-1β(changes within 0,4,8weeks)
- Changes of IL-6(changes within 0,4,8weeks)
- Changes of TNF-α(changes within 0,4,8weeks)