Clinical Efficacy and Benefit of Reducing Metabolic Syndrome by Adjunctive Use of Fute (Flupentixol) in Multi-acting Receptor-targeted Antipsychotics (MARTAs) Treated Schizophrenia Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
Fute (Flupentixol) combined with MARTAs (Multiple-Acting Receptor Targeted Antipsychotics) drugs has its clinical efficacy toward positive symptoms and might reduce the metabolic syndrome-related factors in patients. This study is the first clinical trial to explore the treatment of patients with flupentixol combined with MARTAs. However, due to research limitations, the number of patients who participated in the clinical trial is small, and it depends on subsequent larger-scale clinical trials for more in-depth verification.
详细描述
Objectives
The effects of adjunctive Fute (Flupentixol) with MARTAs (Multiple-Acting Receptor Targeted Antipsychotics) on the metabolic profiles of patients and clinical efficacy of treatment in schizophrenia.
Methodology
It is expected to be admitted to patients with schizophrenia who are over 20 years old and are being treated with MARTAs antipsychotics due to poor treatment efficacy or significant weight gain after use, poor blood sugar control, and other metabolic syndrome-related problems, but Patients who do not meet the medication standards for diabetes or hyperlipidemia, and are willing to accept additional use of Flupentixol after evaluation by the physician.
To compare whether the original MARTAs dose can be effectively reduced after additional use of Flupentixol for at least 12 weeks, whether the symptoms of psychosis have improved, and whether the various factors of metabolic syndrome have improved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
It is expected to be admitted to patients with schizophrenia who are over 20 years old and are being treated with MARTAs antipsychotics due to poor treatment efficacy or significant weight gain after use, poor blood sugar control, and other metabolic syndrome-related problems, but Patients who do not meet the medication standards for diabetes or hyperlipidemia, and are willing to accept additional use of Flupentixol after evaluation by the physician.
To compare whether the original MARTAs dose can be effectively reduced after additional use of Flupentixol for at least 12 weeks, whether the symptoms of psychosis have improved, and whether the various factors of metabolic syndrome have improved.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who suffer from schizophrenia are over 20 years old and are using MARTAs antipsychotics.
排除标准
- •>65y aged Patients.
- •>Other non-schizophrenia disease.
研究组 & 干预措施
MARTAs combined with flupentixol
Flupentixol tablets are indicated for:
• maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity.
Other Names:
Fute tables, Fluanxol
Multi-acting receptor-targeted antipsychotics (MARTAs): clozapine, olanzapine, quetiapine.
干预措施: Flupentixol (Drug)
MARTAs combined with flupentixol
Flupentixol tablets are indicated for:
• maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity.
Other Names:
Fute tables, Fluanxol
Multi-acting receptor-targeted antipsychotics (MARTAs): clozapine, olanzapine, quetiapine.
干预措施: Multi-acting receptor-targeted antipsychotics (MARTAs) (Drug)
Multi-acting receptor-targeted antipsychotics (MARTAs)
clozapine, olanzapine, quetiapine
干预措施: Multi-acting receptor-targeted antipsychotics (MARTAs) (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: 12 weeks
The clinical efficacy of schizophrenia, Positive and Negative Syndrome Scale (PANSS), in patients taking MARTAs combined with Flupentixol for 12 weeks. PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. It is widely used in the study of antipsychotic therapy. The scale is known as the "gold standard" that all assessments of psychotic behavioral disorders should follow. The name refers to the two types of symptoms in schizophrenia, as defined by the American Psychiatric Association: positive symptoms, which refer to an excess or distortion of normal functions (e.g., hallucinations and delusions), and negative symptoms, which represent a diminution or loss of normal functions. Some of these functions which may be lost include normal thoughts, actions, ability to tell fantasies from reality, and the ability to properly express.
Clinical Global Impression-Severity scale (CGI-S)
时间窗: 12 weeks
The clinical efficacy of schizophrenia, Clinical Global Impression-Severity scale (CGI-S), in patients taking MARTAs combined with Flupentixol for 12 weeks. The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. CGI-Severity (CGI-S) which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days.
次要结局
- Fasting blood glucose (FBG) in mg/dL(12 weeks)
- Blood creatinine in mg/dL(12 weeks)
- Glutamine transaminase (r-GT) in U/L(12 weeks)
- Aspartate transaminase (GOT) in U/L(12 weeks)
- Cholesterol in mg/dL(12 weeks)
- High-density lipoprotein (HDL) cholesterol in mg/dL(12 weeks)
- Triglyceride in mg/dL(12 weeks)
- Low-density lipoprotein (LDL) cholesterol in mg/dL(12 weeks)
- Alanine transaminase (GPT) in U/L(12 weeks)