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

NCT04898270 | Completed Phase 4 DMC

• 1 other identifier: SG19331B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Fasting blood glucose (FBG) in mg/dL

  12 weeks

• Cholesterol in mg/dL

  12 weeks

• High-density lipoprotein (HDL) cholesterol in mg/dL

  12 weeks

• Low-density lipoprotein (LDL) cholesterol in mg/dL

  12 weeks

• Blood creatinine in mg/dL

  12 weeks

Study Arms (2)

MARTAs combined with flupentixol

EXPERIMENTAL

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

Multi-acting receptor-targeted antipsychotics (MARTAs)

ACTIVE COMPARATOR

clozapine, olanzapine, quetiapine

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

Interventions

Flupentixol DRUG

Flupentixol tablets are indicated for: • maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity.

Also known as: Fute tables, Fluanxol

MARTAs combined with flupentixol

Multi-acting receptor-targeted antipsychotics (MARTAs) DRUG

Multi-acting receptor-targeted antipsychotics (MARTAs)

MARTAs combined with flupentixol; Multi-acting receptor-targeted antipsychotics (MARTAs)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who suffer from schizophrenia are over 20 years old and are using MARTAs antipsychotics.

You may not qualify if:

• \>65y aged Patients.
• \>Other non-schizophrenia disease.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Metabolic Syndrome; Central Nervous System Diseases

Interventions

Flupenthixol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thioxanthenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chia-Jui Tsai, M.D.

  Taichung Veterans General Hospital (TVGH), Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 24, 2021
• Study Start: December 19, 2019
• Primary Completion: December 31, 2020
• Study Completion: April 20, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)