Schizophrenia Clinical Trial
Official title:
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
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.
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.
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