Schizophrenia; PsychosisPhase 4NCT04898270
Adjunctive Use of Fute (Flupentixol) in Multi-acting Receptor-targeted Antipsychotics Treated Schizophrenia Patients
A Phase 4 study testing Flupentixol and Multi-acting receptor-targeted antipsychotics (MARTAs) in people with Schizophrenia; Psychosis and Metabolic Syndrome, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia; Psychosis, Metabolic Syndrome, Flupentixol
- What is being tested?
- Flupentixol and Multi-acting receptor-targeted antipsychotics (MARTAs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Dec 2019to 20 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who suffer from schizophrenia are over 20 years old and are using MARTAs antipsychotics.
Who cannot join
- >65y aged Patients.
- >Other non-schizophrenia disease.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia; Psychosis, Metabolic Syndrome, Flupentixol, Antipsychotic Agents, Central Nervous System Diseases, Clinical Therapy
- Being tested
- Flupentixol, Multi-acting receptor-targeted antipsychotics (MARTAs)
- Keywords
- Schizophrenia, Metabolic Syndrome, Flupentixol, olanzapine, quetiapine, Central Nervous System Diseases, Clinical Therapy, Antipsychotic Agents
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Metabolic Syndrome, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlupentixolDrug
Also called Fute tables, Fluanxol
Flupentixol tablets are indicated for:
- maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity.
Multi-acting receptor-targeted antipsychotics (MARTAs)Drug
Multi-acting receptor-targeted antipsychotics (MARTAs)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Flupentixol; Drug: Multi-acting receptor-targeted antipsychotics (MARTAs) |
| Multi-acting receptor-targeted antipsychotics (MARTAs) | Active comparator | clozapine, olanzapine, quetiapine Receives: Drug: Multi-acting receptor-targeted antipsychotics (MARTAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (9)
Fasting blood glucose (FBG) in mg/dL
Metabolic syndrome-related factors in patients, fasting blood glucose in mg/dL
Measured: 12 weeks
Cholesterol in mg/dL
Metabolic syndrome-related factors in patients, cholesterol in mg/dL
Measured: 12 weeks
High-density lipoprotein (HDL) cholesterol in mg/dL
Metabolic syndrome-related factors in patients, high-density lipoprotein (HDL) cholesterol in mg/dL
Measured: 12 weeks
Low-density lipoprotein (LDL) cholesterol in mg/dL
Metabolic syndrome-related factors in patients, low-density lipoprotein (LDL) cholesterol in mg/dL
Measured: 12 weeks
Blood creatinine in mg/dL
Metabolic syndrome-related factors in patients, blood creatinine in mg/dL
Measured: 12 weeks
Triglyceride in mg/dL
Metabolic syndrome-related factors in patients, triglyceride in mg/dL
Measured: 12 weeks
Glutamine transaminase (r-GT) in U/L
Metabolic syndrome-related factors in patients, glutamine transaminase (r-GT) in U/L
Measured: 12 weeks
Aspartate transaminase (GOT) in U/L
Metabolic syndrome-related factors in patients, aspartate transaminase (GOT) in U/L
Measured: 12 weeks
Alanine transaminase (GPT) in U/L
Metabolic syndrome-related factors in patients, alanine transaminase (GPT) in U/L
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start19 Dec 2019
- Primary completion31 Dec 2020
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Jui Tsai, M.D., Principal investigator, Taichung Veterans General Hospital (TVGH), Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898270
- Sponsor's protocol ID
- SG19331B
- Status last verified
- May 2021
- First submitted
- 23 Apr 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consider patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04898270
- Acronym / sponsor ID
- SG19331B
- Conditions
- Schizophrenia; Psychosis, Metabolic Syndrome, Flupentixol, Antipsychotic Agents, Central Nervous System Diseases, Clinical Therapy
- Keywords
- Schizophrenia, Metabolic Syndrome, Flupentixol, olanzapine, quetiapine, Central Nervous System Diseases, Clinical Therapy, Antipsychotic Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MARTAs combined with flupentixol | Experimental | Drug: Flupentixol, Drug: Multi-acting receptor-targeted antipsychotics (MARTAs)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. |
| Multi-acting receptor-targeted antipsychotics (MARTAs) | Active comparator | Drug: Multi-acting receptor-targeted antipsychotics (MARTAs)clozapine, olanzapine, quetiapine |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who suffer from schizophrenia are over 20 years old and are using MARTAs antipsychotics.
Key exclusion criteria (2 listed)
- >65y aged Patients.
- >Other non-schizophrenia disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlupentixolAlso: Fute tables, FluanxolFlupentixol tablets are indicated for: • maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity. | Drug | MARTAs combined with flupentixol |
| Multi-acting receptor-targeted antipsychotics (MARTAs)Multi-acting receptor-targeted antipsychotics (MARTAs) | Drug | MARTAs combined with flupentixol, Multi-acting receptor-targeted antipsychotics (MARTAs) |
Primary outcome
Clinical Global Impression-Severity scale (CGI-S)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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.
9 secondary outcomes
Fasting blood glucose (FBG) in mg/dL
Time frame: 12 weeks
Cholesterol in mg/dL
Time frame: 12 weeks
High-density lipoprotein (HDL) cholesterol in mg/dL
Time frame: 12 weeks
Low-density lipoprotein (LDL) cholesterol in mg/dL
Time frame: 12 weeks
Blood creatinine in mg/dL
Time frame: 12 weeks
Triglyceride in mg/dL
Time frame: 12 weeks
Glutamine transaminase (r-GT) in U/L
Time frame: 12 weeks
Aspartate transaminase (GOT) in U/L
Time frame: 12 weeks
Alanine transaminase (GPT) in U/L
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No. Consider patient privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Jui Tsai, M.D. principal investigator
Taichung Veterans General Hospital (TVGH), Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flupentixol and Multi-acting receptor-targeted antipsychotics (MARTAs) in people with Schizophrenia; Psychosis and Metabolic Syndrome, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression-Severity scale (CGI-S) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.