Effects of Lurasidone on Left Ventricle Systolic Functions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-06-01

Brief Summary

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The goal of our study to learn if lurasidone molecule which is used on patients with schizophrenia or bipolar disorder has any cardiotoxic effect.

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Detailed Description

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Lurasidone is an atypical antipsychotic drug used both on patients with schizophrenia or bipolar disorder. It improves patients' clinical symptoms through dopamine D2 and serotonin 5-HT2A receptor antagonism. However, the effect of antipsychotic drugs on cardiac functions is an important parameter for patient safety during the treatment process. Although the existing literature on the cardiac effects of lurasidone is limited, atypical antipsychotic are known to cause corrected QT interval prolongation, arrhythmias and suppression on cardiac functions. Studies show that these cardiac side effects are mostly related to clozapine which is a D2 and 5-HT2A antagonist such as lurasidone. Though not fully understood, it is thought that cardiac events due to antipsychotic drugs occur because of type 1 hypersensitivity and rising levels of pro-inflammatory cytokines. It might also be related to ischemia that free oxygen radicals initiate at the molecular level.

D2 receptors play a critical role in the regulation of heart rate and vascular tone. D2 receptor antagonism may increase the risk of hypertension by changing systemic vascular resistance and heart rate. In addition, inhibition of D2 receptors may lead to loss of the vasodilator effects of dopamine, leading to impaired cardiovascular homeostasis. Similarly 5-HT2A receptors have important effects of cardiac functions. 5-HT2A receptor antagonism, together with imbalances in serotonin levels, may increase heart rate and affect vascular tone, leading to vasoconstriction. It is possible that the increase in systemic vascular resistance and cardiac inotropy through receptor antagonism may cause deterioration in cardiac functions and should be considered in clinical follow-up.

There are a limited number of studies examining the potential effects of lurasidone on cardiac functions. For example, one study reported that lurasidone treatment did not cause a significant prolongation of the QTc interval, while another study reported that the overall cardiac safety profile of lurasidone use was quite favorable. However, more data are needed to compare cardiac side effects between lurasidone and other antipsychotics and how these effects should be managed in clinical practice. The aim of this study is to gain information about the possible cardiac effects of the lurasidone molecule by evaluating left ventricular systolic function with the help of periodic transthoracic echocardiography. In particular, clarifying the potential risks of lurasidone on cardiac health and the clinical significance of these risks is important both to increase patient safety and to optimize treatment processes.

Conditions

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Lurasidone Cardiotoxicity Schizophrenia Patients Bipolar Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients on Lurasidone

Patient who are admitted by the psychiatry clinic of our center and meet the inclusion criteria

Global Longitudinal Strain

Intervention Type DIAGNOSTIC_TEST

Global longitudinal strain measurement is a more objective method to determine left ventricular systolic function than traditional eyeballing method. It helps to detect and quantify subtle changes even so it is an emerging method to evaluate the cardiotoxicity of chemotherapeutic drugs. It is planned to compare each selected patient's GLS measurement before starting to use lurasidone and after six months of using it. Hereby our aim is to find if lurasidone has any effect on left ventricular systolic function.

Interventions

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Global Longitudinal Strain

Global longitudinal strain measurement is a more objective method to determine left ventricular systolic function than traditional eyeballing method. It helps to detect and quantify subtle changes even so it is an emerging method to evaluate the cardiotoxicity of chemotherapeutic drugs. It is planned to compare each selected patient's GLS measurement before starting to use lurasidone and after six months of using it. Hereby our aim is to find if lurasidone has any effect on left ventricular systolic function.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aged 18 to 65 years
* Diagnosed with schizophrenia or bipolar disorder by the psychiatry clinic of our center and indicated to use lurasidone molecule
* Hasn't been diagnosed with coronary artery disease, any kind of heart failure or severe valvular disease