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

Primary Purpose

Schizophrenia; Psychosis, Metabolic Syndrome, Flupentixol

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Flupentixol
Multi-acting receptor-targeted antipsychotics (MARTAs)
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia; Psychosis focused on measuring Schizophrenia, Metabolic Syndrome, Flupentixol, olanzapine, quetiapine, Central Nervous System Diseases, Clinical Therapy, Antipsychotic Agents

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MARTAs combined with flupentixol

Multi-acting receptor-targeted antipsychotics (MARTAs)

Arm Description

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.

clozapine, olanzapine, quetiapine

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2021
Last Updated
May 20, 2021
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04898270
Brief Title
Adjunctive Use of Fute (Flupentixol) in Multi-acting Receptor-targeted Antipsychotics Treated Schizophrenia Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
April 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia; Psychosis, Metabolic Syndrome, Flupentixol, Antipsychotic Agents, Central Nervous System Diseases, Clinical Therapy, Olanzapine, Quetiapine
Keywords
Schizophrenia, Metabolic Syndrome, Flupentixol, olanzapine, quetiapine, Central Nervous System Diseases, Clinical Therapy, Antipsychotic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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
Participant
Masking 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.
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MARTAs combined with flupentixol
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi-acting receptor-targeted antipsychotics (MARTAs)
Arm Type
Active Comparator
Arm Description
clozapine, olanzapine, quetiapine
Intervention Type
Drug
Intervention Name(s)
Flupentixol
Other Intervention Name(s)
Fute tables, Fluanxol
Intervention Description
Flupentixol tablets are indicated for: • maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity.
Intervention Type
Drug
Intervention Name(s)
Multi-acting receptor-targeted antipsychotics (MARTAs)
Intervention Description
Multi-acting receptor-targeted antipsychotics (MARTAs)
Primary Outcome Measure Information:
Title
Clinical Global Impression-Severity scale (CGI-S)
Description
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.
Time Frame
12 weeks
Title
Positive and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fasting blood glucose (FBG) in mg/dL
Description
Metabolic syndrome-related factors in patients, fasting blood glucose in mg/dL
Time Frame
12 weeks
Title
Cholesterol in mg/dL
Description
Metabolic syndrome-related factors in patients, cholesterol in mg/dL
Time Frame
12 weeks
Title
High-density lipoprotein (HDL) cholesterol in mg/dL
Description
Metabolic syndrome-related factors in patients, high-density lipoprotein (HDL) cholesterol in mg/dL
Time Frame
12 weeks
Title
Low-density lipoprotein (LDL) cholesterol in mg/dL
Description
Metabolic syndrome-related factors in patients, low-density lipoprotein (LDL) cholesterol in mg/dL
Time Frame
12 weeks
Title
Blood creatinine in mg/dL
Description
Metabolic syndrome-related factors in patients, blood creatinine in mg/dL
Time Frame
12 weeks
Title
Triglyceride in mg/dL
Description
Metabolic syndrome-related factors in patients, triglyceride in mg/dL
Time Frame
12 weeks
Title
Glutamine transaminase (r-GT) in U/L
Description
Metabolic syndrome-related factors in patients, glutamine transaminase (r-GT) in U/L
Time Frame
12 weeks
Title
Aspartate transaminase (GOT) in U/L
Description
Metabolic syndrome-related factors in patients, aspartate transaminase (GOT) in U/L
Time Frame
12 weeks
Title
Alanine transaminase (GPT) in U/L
Description
Metabolic syndrome-related factors in patients, alanine transaminase (GPT) in U/L
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Jui Tsai, M.D.
Organizational Affiliation
Taichung Veterans General Hospital (TVGH), Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Consider patient privacy.

Learn more about this trial

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

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