Adjunctive Use of Fute (Flupentixol) in Multi-acting Receptor-targeted Antipsychotics Treated Schizophrenia Patients
Condition: Schizophrenia; Psychosis; Metabolic Syndrome; Flupentixol; Antipsychotic Agents; Central Nervous System Diseases; Clinical Therapy; Olanzapine; Quetiapine
MeSH terms: Nervous System Diseases; Central Nervous System Diseases; Metabolic Syndrome; Syndrome; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.

      Number of patients

      It is estimated that 30 subjects will be recruited to participate in this clinical trial.
      This report is an interim report with the results of 15 subjects.

      Diagnosis and main criteria for inclusion

      Patients suffering from schizophrenia who are over 20 years old and are using MARTAs
      antipsychotics.

      Test product, dose and mode of administration, batch number

      Fute F.C. Tablets (Flupentixol), the clinically recommended dosage should be adjusted
      according to the individual conditions of the patients. Generally speaking, a low dose should
      be administered at the beginning. Then the dosage is increased according to the treatment
      response to achieve the appropriate curative effect as soon as possible. The maintenance dose
      is usually administered as a single dose in the morning, and the maintenance dose is usually
      5-20 mg/day.

      The initial dose is 3-15 mg/day, divided into 2-3 administrations, and can be increased to 40
      mg/day if necessary.
    

Intervention name(s): Flupentixol; Multi-acting receptor-targeted antipsychotics (MARTAs)
Intervention type(s): Drug; Drug
Intervention description(s): Flupentixol tablets are indicated for:
• maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity.; Multi-acting receptor-targeted antipsychotics (MARTAs)
Other intervention name(s): Fute tables; Fluanxol
Intervention MeSH terms: Antipsychotic Agents; Flupenthixol; Flupenthixol decanoate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Schizophrenia; Metabolic Syndrome; Flupentixol; olanzapine; quetiapine; Central Nervous System Diseases; Clinical Therapy; Antipsychotic Agents