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

T

Taichung Veterans General Hospital

Status and phase

Completed
Phase 4

Conditions

Flupentixol
Antipsychotic Agents
Quetiapine
Central Nervous System Diseases
Schizophrenia; Psychosis
Clinical Therapy
Olanzapine
Metabolic Syndrome

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04898270
SG19331B

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

30 participants in 2 patient groups

MARTAs combined with flupentixol
Experimental group
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.
Treatment:
Drug: Multi-acting receptor-targeted antipsychotics (MARTAs)
Drug: Flupentixol
Multi-acting receptor-targeted antipsychotics (MARTAs)
Active Comparator group
Description:
clozapine, olanzapine, quetiapine
Treatment:
Drug: Multi-acting receptor-targeted antipsychotics (MARTAs)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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