SchizophreniaPhase 4NCT04446234
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
A Phase 4 study testing Risperidone, Aripiprazole and Ziprasidone in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this study was to investigate the effect of atypical antipsychotics on cardiac safety. The secondary purpose was to understand the rate of QTc prolongation in electrocardiogram induced by atypical antipsychotics. And try to construct the model of cardiac monitoring index. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone, Aripiprazole and Ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- May 2021to 31 Dec 2022
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Phase one:Effects of different types of atypical antipsychotics on cardiac safety.
- Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks
- Han ethnic, 18-45 years old;
- Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.
- Willing to participate in the trial and receive treatment;
- Course of disease within 2 years;
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- Able to communicate effectively with the researcher and complete the written informed consent signed by hand.
- Phase two:Construction of cardiac safety monitoring model
- Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks
- Han ethnic, 18-45 years old;
- Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.
- Willing to participate in the trial and receive treatment;
- Serious arrhythmia, myocarditis, cardiomyopathy and cardiac insufficiency during taking medicine;
- Able to communicate effectively with the researcher and complete the written informed consent signed by hand.
Who cannot join
- (1) Participating in other clinical studies; (2) Combination of DSM-IV diagnoses other than schizophrenia; (3) History of heart disease; (4) History of drug abuse in the previous 6 months; (5) Pregnant or in the first three months of lactation; (6) Combination of antipsychotics, mood stabilizers and antidepressants was used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate the effect of atypical antipsychotics on cardiac safety. The secondary purpose was to understand the rate of QTc prolongation in electrocardiogram induced by atypical antipsychotics. And try to construct the model of cardiac monitoring index. We conducted a randomized trial in which patients with schizophrenia who were first on or off medication for more than two weeks took a single atypical antipsychotic (Risperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine) for 12 weeks and monitored changes in biochemical, electrocardiogram and other indicators. And then 50 patients with adverse cardiac reactions (ADRs) taking antipsychotics were selected to review the data, analyze and construct a monitoring model.
We hypothesized that atypical antipsychotics with different mechanisms of action have different effects on cardiac safety in patients with schizophrenia, and that they are applicable to different populations. The monitoring index model can reduce the occurrence of cardiotoxicity and improve the prognosis.
Read the detailed description
Atypical antipsychotics, also known as new antipsychotics, are a group of drugs that act on the central nervous system to treat schizophrenia, psychotic disorder or bipolar disorder. Compared with typical antipsychotics, atypical antipsychotics have the advantages of good efficacy and fewer side effects. Therefore, currently, atypical antipsychotics are widely used in clinical practice. In recent years, the effects of atypical antipsychotics on metabolism and cardiovascular system have attracted more and more clinical attention. Studies have found that long-term use of atypical antipsychotics can lead to arrhythmias, drug-induced myocarditis, and even cardiac arrest. Since antipsychotics can cause cardiac adverse events in patients with schizophrenia, accompanied by medical complications, resulting in a generally shorter life span of 15-25 years compared with the general population, cardiac safety assessment of drugs for patients with schizophrenia is becoming increasingly important. But the domestic study of antipsychotics in the cardiovascular field, especially about the safety of heart systemic evaluation are few and far between, so this research has focused on patients with schizophrenia in China people use different mechanisms of atypical antipsychotics (Risperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine) on heart safety.
In the first stage, a total of 350 schizophrenia patients were enrolled who were either not on medication for the first time or stopped for more than 2 weeks. They were treated with atypical antipsychotics respectively, follow-up of 12 weeks, evaluating the effects of antipsychotics on cardiac function and structure in patients with schizophrenia from general data, biochemistry, electrocardiogram, etc. In the second stage, 50 patients of adverse cardiac reactions caused by taking antipsychotics were selected from enrolled subjects, and a retrospective analysis(day1, week4, week12, and week24) was conducted to try to build a cardiac safety detection indicator model, so as to understand the impact of antipsychotics on cardiac safety. More rational use of antipsychotics in the context of ensuring clinical efficacy and minimum side effects, and the use of monitoring indicator models to reduce the occurrence of cardiac toxicity, improve the safety of antipsychotics in use.
- Conditions
- Schizophrenia
- Being tested
- Risperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine
- Keywords
- Atypical antipsychotics, Cardiac safety, Model building
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Use medicine according to patients condition
AripiprazoleDrug
Use medicine according to patients condition
ZiprasidoneDrug
Use medicine according to patients condition
AmisulprideDrug
Use medicine according to patients condition
QuetiapineDrug
Use medicine according to patients condition
| Study group | Role | What they receive |
|---|---|---|
| Risperidone | Experimental | Risperidone tablet Receives: Drug: Risperidone |
| Aripiprazole | Experimental | Aripiprazole tablet Receives: Drug: Aripiprazole |
| Ziprasidone | Experimental | Ziprasidone tablet Receives: Drug: Ziprasidone |
| Amisulpride | Experimental | Amisulpride tablet Receives: Drug: Amisulpride |
| Quetiapine | Experimental | Quetiapine tablet Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac QTc(corrected QT interval) interphase changes after drug administration.
Cardiac QTc interphase changes during the study duration
Measured: baseline, week2,4, 8, 12，24
Secondary outcomes (5)
Biochemical index： BNP(Brain Natriuretic Peptide)
Changes of biochemical indexes during the study duration
Measured: baseline, week2,4, 8, 12，24
Biochemical index：troponin
Changes of biochemical indexes during the study duration
Measured: baseline, week2,4, 8, 12，24
Biochemical index： myoglobin
Changes of biochemical indexes during the study duration
Measured: baseline, week2,4, 8, 12，24
Electrocardiogram：Heart rate
Changes of ECG indicators during the study duration
Measured: baseline, week2,4, 8, 12，24
Echocardiographic: EF(Ejection Fraction) value
Changes of cardiac ultrasound indicators during the study duration
Measured: baseline, week2,4, 8, 12，24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study startMay 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- LV QINYU, Principal investigator, SHANGHAI MENTAL HEALTH CENTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446234
- Sponsor's protocol ID
- YG2019QNB07
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
- ClinicalTrials.gov ID
- NCT04446234
- Acronym / sponsor ID
- YG2019QNB07
- Conditions
- Schizophrenia
- Keywords
- Atypical antipsychotics, Cardiac safety, Model building
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- May 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Jun 2020 (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.
The purpose of this study was to investigate the effect of atypical antipsychotics on cardiac safety. The secondary purpose was to understand the rate of QTc prolongation in electrocardiogram induced by atypical antipsychotics. And try to construct the model of cardiac monitoring index. We conducted a randomized trial in which patients with schizophrenia who were first on or off medication for more than two weeks took a single atypical antipsychotic (Risperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine) for 12 weeks and monitored changes in biochemical, electrocardiogram and other indicators. And then 50 patients with adverse cardiac reactions (ADRs) taking antipsychotics were selected to review the data, analyze and construct a monitoring model.
We hypothesized that atypical antipsychotics with different mechanisms of action have different effects on cardiac safety in patients with schizophrenia, and that they are applicable to different populations. The monitoring index model can reduce the occurrence of cardiotoxicity and improve the prognosis.
Detailed description
Atypical antipsychotics, also known as new antipsychotics, are a group of drugs that act on the central nervous system to treat schizophrenia, psychotic disorder or bipolar disorder. Compared with typical antipsychotics, atypical antipsychotics have the advantages of good efficacy and fewer side effects. Therefore, currently, atypical antipsychotics are widely used in clinical practice. In recent years, the effects of atypical antipsychotics on metabolism and cardiovascular system have attracted more and more clinical attention. Studies have found that long-term use of atypical antipsychotics can lead to arrhythmias, drug-induced myocarditis, and even cardiac arrest. Since antipsychotics can cause cardiac adverse events in patients with schizophrenia, accompanied by medical complications, resulting in a generally shorter life span of 15-25 years compared with the general population, cardiac safety assessment of drugs for patients with schizophrenia is becoming increasingly important. But the domestic study of antipsychotics in the cardiovascular field, especially about the safety of heart systemic evaluation are few and far between, so this research has focused on patients with schizophrenia in China people use different mechanisms of atypical antipsychotics (Risperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine) on heart safety.
In the first stage, a total of 350 schizophrenia patients were enrolled who were either not on medication for the first time or stopped for more than 2 weeks. They were treated with atypical antipsychotics respectively, follow-up of 12 weeks, evaluating the effects of antipsychotics on cardiac function and structure in patients with schizophrenia from general data, biochemistry, electrocardiogram, etc. In the second stage, 50 patients of adverse cardiac reactions caused by taking antipsychotics were selected from enrolled subjects, and a retrospective analysis(day1, week4, week12, and week24) was conducted to try to build a cardiac safety detection indicator model, so as to understand the impact of antipsychotics on cardiac safety. More rational use of antipsychotics in the context of ensuring clinical efficacy and minimum side effects, and the use of monitoring indicator models to reduce the occurrence of cardiac toxicity, improve the safety of antipsychotics in use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Risperidone | Experimental | Drug: RisperidoneRisperidone tablet |
| Aripiprazole | Experimental | Drug: AripiprazoleAripiprazole tablet |
| Ziprasidone | Experimental | Drug: ZiprasidoneZiprasidone tablet |
| Amisulpride | Experimental | Drug: AmisulprideAmisulpride tablet |
| Quetiapine | Experimental | Drug: QuetiapineQuetiapine tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Phase one:Effects of different types of atypical antipsychotics on cardiac safety.
- Phase two:Construction of cardiac safety monitoring model
- Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks
- Han ethnic, 18-45 years old;
- Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.
Key exclusion criteria (1 listed)
- (1) Participating in other clinical studies; (2) Combination of DSM-IV diagnoses other than schizophrenia; (3) History of heart disease; (4) History of drug abuse in the previous 6 months; (5) Pregnant or in the first three months of lactation; (6) Combination of antipsychotics, mood stabilizers and antidepressants was used in the study.
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 |
|---|---|---|
| RisperidoneUse medicine according to patients condition | Drug | Risperidone |
| AripiprazoleUse medicine according to patients condition | Drug | Aripiprazole |
| ZiprasidoneUse medicine according to patients condition | Drug | Ziprasidone |
| AmisulprideUse medicine according to patients condition | Drug | Amisulpride |
| QuetiapineUse medicine according to patients condition | Drug | Quetiapine |
Primary outcome
Cardiac QTc(corrected QT interval) interphase changes after drug administration.
Time frame: baseline, week2,4, 8, 12，24
Cardiac QTc interphase changes during the study duration
5 secondary outcomes
Biochemical index： BNP(Brain Natriuretic Peptide)
Time frame: baseline, week2,4, 8, 12，24
Biochemical index：troponin
Time frame: baseline, week2,4, 8, 12，24
Biochemical index： myoglobin
Time frame: baseline, week2,4, 8, 12，24
Electrocardiogram：Heart rate
Time frame: baseline, week2,4, 8, 12，24
Echocardiographic: EF(Ejection Fraction) value
Time frame: baseline, week2,4, 8, 12，24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
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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.
LV QINYU principal investigator
SHANGHAI MENTAL HEALTH CENTRE
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 Risperidone, Aripiprazole and Ziprasidone in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
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 14 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LV QINYU (18017311158, 18616550357@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac QTc(corrected QT interval) interphase changes after drug administration. (time frame: baseline, week2,4, 8, 12，24). 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 26 Aug 2020.