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Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04446234
Enrollment
350
Registered
2020-06-24
Start date
2021-05-31
Completion date
2022-12-31
Last updated
2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Atypical antipsychotics, Cardiac safety, Model building

Brief 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. 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.

Interventions

DRUGRisperidone

Use medicine according to patients condition

DRUGAripiprazole

Use medicine according to patients condition

DRUGZiprasidone

Use medicine according to patients condition

DRUGAmisulpride

Use medicine according to patients condition

DRUGQuetiapine

Use medicine according to patients condition

Sponsors

Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Phase one:Effects of different types of atypical antipsychotics on cardiac safety. 1. 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 2. Han ethnic, 18-45 years old; 3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts. 4. Willing to participate in the trial and receive treatment; 5. Course of disease within 2 years; 6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand. Phase two:Construction of cardiac safety monitoring model 1. 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 2. Han ethnic, 18-45 years old; 3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts. 4. Willing to participate in the trial and receive treatment; 5. Serious arrhythmia, myocarditis, cardiomyopathy and cardiac insufficiency during taking medicine; 6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand.

Exclusion criteria

* (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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac QTc(corrected QT interval) interphase changes after drug administration.baseline, week2,4, 8, 12,24Cardiac QTc interphase changes during the study duration

Secondary

MeasureTime frameDescription
Biochemical index: BNP(Brain Natriuretic Peptide)baseline, week2,4, 8, 12,24Changes of biochemical indexes during the study duration
Biochemical index:troponinbaseline, week2,4, 8, 12,24Changes of biochemical indexes during the study duration
Biochemical index: myoglobinbaseline, week2,4, 8, 12,24Changes of biochemical indexes during the study duration
Electrocardiogram:Heart ratebaseline, week2,4, 8, 12,24Changes of ECG indicators during the study duration
Echocardiographic: EF(Ejection Fraction) valuebaseline, week2,4, 8, 12,24Changes of cardiac ultrasound indicators during the study duration

Countries

China

Contacts

Primary ContactLV QINYU
18616550357@163.com18017311158
Backup ContactYI ZHENGHUI
yizhenghui1971@163.com18017311007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026