drugset / Trial / NCT04446234

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

NCT04446234

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-05
Primary completion
2022-12-31
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amisulpride Small molecule
Subject Aripiprazole Other / unclassified
Subject Quetiapine Small molecule
Subject Risperidone Other / unclassified
Subject Ziprasidone Small molecule

Indications