Berberine Effect on Cytokine, CRP, Metabolic Disturbance as an Adjunctive Therapy in Schizophrenia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change of glucose
研究概览
简要总结
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.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Berberine group
Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.
干预措施: Berberine (Drug)
Placebo group
Accept placebo(300 mg/tid)+SGAs monotherapy.
干预措施: Placebo (Drug)
结局指标
主要结局
The change of glucose
时间窗: Change from Baseline Glucose at 12 weeks
The change of CRP
时间窗: Change from Baseline CRP at 12 weeks
The change of IL-1β
时间窗: Change from Baseline IL-1β at 12 weeks
The change of lipid profile
时间窗: Change from Baseline lipid profile at 12 weeks
The change of IL-6
时间窗: Change from Baseline IL-6 at 12 weeks
The change of Cognitive function assessed with The MATRICS Consensus Cognitive Battery (MCCB)
时间窗: Change from Baseline Cognitive function at 12 weeks
The MATRICS Consensus Cognitive Battery (MCCB) for Cognitive function
The change of insulin
时间窗: Change from Baseline insulin at 12 weeks
The change of HbA1c
时间窗: Change from Baseline HbA1c at 12 weeks
The change of TNF-α
时间窗: Change from Baseline TNF-α at 12 weeks
次要结局
- The change of clinical symptoms assessed with The Positive and Negative Syndrome Scale(Change from Baseline clinical symptoms at 12 weeks)
- Adverse event(At 12 weeks)