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

Metabolic Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04898270
• Other study ID #: SG19331B
• Status: Completed
• Phase: Phase 4
• Start date: December 19, 2019
• Est. completion date: April 20, 2021

Study information

• Verified date: May 2021
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antipsychotic Agents
• Central Nervous System Diseases
• Metabolic Syndrome
• Nervous System Diseases
• Olanzapine
• Schizophrenia
• Schizophrenia; Psychosis
• Syndrome

Intervention

Drug:
• Flupentixol
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)
Multi-acting receptor-targeted antipsychotics (MARTAs)

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression-Severity scale (CGI-S)	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.	12 weeks
Primary	Positive and Negative Syndrome Scale (PANSS)	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.	12 weeks
Secondary	Fasting blood glucose (FBG) in mg/dL	Metabolic syndrome-related factors in patients, fasting blood glucose in mg/dL	12 weeks
Secondary	Cholesterol in mg/dL	Metabolic syndrome-related factors in patients, cholesterol in mg/dL	12 weeks
Secondary	High-density lipoprotein (HDL) cholesterol in mg/dL	Metabolic syndrome-related factors in patients, high-density lipoprotein (HDL) cholesterol in mg/dL	12 weeks
Secondary	Low-density lipoprotein (LDL) cholesterol in mg/dL	Metabolic syndrome-related factors in patients, low-density lipoprotein (LDL) cholesterol in mg/dL	12 weeks
Secondary	Blood creatinine in mg/dL	Metabolic syndrome-related factors in patients, blood creatinine in mg/dL	12 weeks
Secondary	Triglyceride in mg/dL	Metabolic syndrome-related factors in patients, triglyceride in mg/dL	12 weeks
Secondary	Glutamine transaminase (r-GT) in U/L	Metabolic syndrome-related factors in patients, glutamine transaminase (r-GT) in U/L	12 weeks
Secondary	Aspartate transaminase (GOT) in U/L	Metabolic syndrome-related factors in patients, aspartate transaminase (GOT) in U/L	12 weeks
Secondary	Alanine transaminase (GPT) in U/L	Metabolic syndrome-related factors in patients, alanine transaminase (GPT) in U/L	12 weeks