Clinical trial NCT04898270: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Global Impression-Severity scale (CGI-S)
timeFrame: 12 weeks
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting blood glucose (FBG) in mg/dL
timeFrame: 12 weeks
measure: Cholesterol in mg/dL
timeFrame: 12 weeks
measure: High-density lipoprotein (HDL) cholesterol in mg/dL
timeFrame: 12 weeks
measure: Low-density lipoprotein (LDL) cholesterol in mg/dL
timeFrame: 12 weeks
measure: Blood creatinine in mg/dL
timeFrame: 12 weeks
measure: Triglyceride in mg/dL
timeFrame: 12 weeks
measure: Glutamine transaminase (r-GT) in U/L
timeFrame: 12 weeks
measure: Aspartate transaminase (GOT) in U/L
timeFrame: 12 weeks
measure: Alanine transaminase (GPT) in U/L
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital (TVGH), Taiwan
name: Chia-Jui Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
References: