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

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

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases; Metabolic Syndrome; Schizophrenia; Psychosis; Antipsychotic Agents; Olanzapine; Flupentixol; Clinical Therapy; Quetiapine
• Intervention / Treatment: Drug: Flupentixol; Drug: Multi-acting receptor-targeted antipsychotics (MARTAs)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Drug: Multi-acting receptor-targeted antipsychotics (MARTAs); Multi-acting receptor-targeted antipsychotics (MARTAs)
Active Comparator: Multi-acting receptor-targeted antipsychotics (MARTAs); clozapine, olanzapine, quetiapine	Drug: Multi-acting receptor-targeted antipsychotics (MARTAs); Multi-acting receptor-targeted antipsychotics (MARTAs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose (FBG) in mg/dL	Metabolic syndrome-related factors in patients, fasting blood glucose in mg/dL	12 weeks
Cholesterol in mg/dL	Metabolic syndrome-related factors in patients, cholesterol in mg/dL	12 weeks
High-density lipoprotein (HDL) cholesterol in mg/dL	Metabolic syndrome-related factors in patients, high-density lipoprotein (HDL) cholesterol in mg/dL	12 weeks
Low-density lipoprotein (LDL) cholesterol in mg/dL	Metabolic syndrome-related factors in patients, low-density lipoprotein (LDL) cholesterol in mg/dL	12 weeks
Blood creatinine in mg/dL	Metabolic syndrome-related factors in patients, blood creatinine in mg/dL	12 weeks
Triglyceride in mg/dL	Metabolic syndrome-related factors in patients, triglyceride in mg/dL	12 weeks
Glutamine transaminase (r-GT) in U/L	Metabolic syndrome-related factors in patients, glutamine transaminase (r-GT) in U/L	12 weeks
Aspartate transaminase (GOT) in U/L	Metabolic syndrome-related factors in patients, aspartate transaminase (GOT) in U/L	12 weeks
Alanine transaminase (GPT) in U/L	Metabolic syndrome-related factors in patients, alanine transaminase (GPT) in U/L	12 weeks

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Chia-Jui Tsai, M.D., Taichung Veterans General Hospital (TVGH), Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): April 20, 2021

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Schizophrenia; Metabolic Syndrome; quetiapine; olanzapine; Central Nervous System Diseases; Antipsychotic Agents; Flupentixol; Clinical Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Schizophrenia Spectrum and Other Psychotic Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Schizophrenia; Metabolic Syndrome; Nervous System Diseases; Central Nervous System Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Antipsychotic Agents; Flupenthixol; Flupenthixol decanoate
• Other Study ID Numbers: SG19331B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Consider patient privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No