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NCT Number: NCT04898270

Adjunctive Use of Fute (Flupentixol) in Multi-acting Receptor-targeted Antipsychotics Treated Schizophrenia Patients

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.

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Key information

Conditions

Schizophrenia; Psychosis Antipsychotic Agents Central Nervous System Diseases Clinical Therapy Flupentixol Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutritional and Metabolic Diseases Olanzapine Psychotic Disorders Quetiapine Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who suffer from schizophrenia are over 20 years old and are using MARTAs antipsychotics.

Exclusion criteria

  • >65y aged Patients.
  • >Other non-schizophrenia disease.

Treatment and study plan

Flupentixol

Drug

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)

Drug

Multi-acting receptor-targeted antipsychotics (MARTAs)

Primary outcomes

  1. Clinical Global Impression-Severity scale (CGI-S)

    Time frame: 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.

  2. Positive and Negative Syndrome Scale (PANSS)

    Time frame: 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.

Secondary outcomes

  1. Fasting blood glucose (FBG) in mg/dL

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, fasting blood glucose in mg/dL

  2. Cholesterol in mg/dL

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, cholesterol in mg/dL

  3. High-density lipoprotein (HDL) cholesterol in mg/dL

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, high-density lipoprotein (HDL) cholesterol in mg/dL

  4. Low-density lipoprotein (LDL) cholesterol in mg/dL

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, low-density lipoprotein (LDL) cholesterol in mg/dL

  5. Blood creatinine in mg/dL

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, blood creatinine in mg/dL

  6. Triglyceride in mg/dL

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, triglyceride in mg/dL

  7. Glutamine transaminase (r-GT) in U/L

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, glutamine transaminase (r-GT) in U/L

  8. Aspartate transaminase (GOT) in U/L

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, aspartate transaminase (GOT) in U/L

  9. Alanine transaminase (GPT) in U/L

    Time frame: 12 weeks

    Metabolic syndrome-related factors in patients, alanine transaminase (GPT) in U/L

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Clinical Efficacy and Benefit of Reducing Metabolic Syndrome by Adjunctive Use of Fute (Flupentixol) in Multi-acting Receptor-targeted Antipsychotics (MARTAs) Treated Schizophrenia Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 24, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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