Clinical trial NCT06695676: Effects of Lurasidone on Left Ventricle Systolic Functions
Official title: Evaluation of Left Ventricle Systolic Functions of Patients On Lurasidone
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lurasidone Cardiotoxicity
Schizophrenia Patients
Bipolar Disorders
Keywords: Global Longitudinal Strain
Cardiotoxicity
Lurasidone
antipsychotic drugs
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who apply to Adnan Menderes University Psychiatry Clinic and meet the criteria of inclusion

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

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* Patients who do not agree to participate to the trial
* Patient who do not meet the inclusion criteria

Primary outcomes:
measure: Lurasidone molecule will affect left ventricular systolic function
timeFrame: All patients whom are admitted by our psychiatry clinic for the next 6 months will be included.
Secondary outcomes:
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Adnan Menderes University
state: Zafer
Study officials:
References:
citation: Slawinski G, Hawryszko M, Lizewska-Springer A, Nabialek-Trojanowska I, Lewicka E. Global Longitudinal Strain in Cardio-Oncology: A Review. Cancers (Basel). 2023 Feb 3;15(3):986. doi: 10.3390/cancers15030986.
citation: Alawami M, Wasywich C, Cicovic A, Kenedi C. A systematic review of clozapine induced cardiomyopathy. Int J Cardiol. 2014 Sep 20;176(2):315-20. doi: 10.1016/j.ijcard.2014.07.103. Epub 2014 Aug 1.
citation: Curto M, Girardi N, Lionetto L, Ciavarella GM, Ferracuti S, Baldessarini RJ. Systematic Review of Clozapine Cardiotoxicity. Curr Psychiatry Rep. 2016 Jul;18(7):68. doi: 10.1007/s11920-016-0704-3.