Lurasidone CardiotoxicityLurasidoneNCT06695676
Effects of Lurasidone on Left Ventricle Systolic Functions
An observational study of Lurasidone Cardiotoxicity and Schizophrenia Patients, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lurasidone Cardiotoxicity, Schizophrenia Patients, Bipolar Disorders
- What is being tested?
- Global Longitudinal Strain
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2024to 1 Jun 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who apply to Adnan Menderes University Psychiatry Clinic and meet the criteria of inclusion
Who may be able to join
- 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
Who cannot join
- Patients who do not agree to participate to the trial
- Patient who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adnan Menderes University
Aydin, Zafer, 9010
Sevil Gulasti, +905054513277, drsevilonay@hotmail.com
Maide Gizem Cevik, +905348223574
About this study
Official title: Evaluation of Left Ventricle Systolic Functions of Patients On Lurasidone
The goal of our study to learn if lurasidone molecule which is used on patients with schizophrenia or bipolar disorder has any cardiotoxic effect.
Read the 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.
- Being tested
- Global Longitudinal Strain
- Keywords
- Global Longitudinal Strain, Cardiotoxicity, Lurasidone, antipsychotic drugs
- Medical subject headings
- Bipolar Disorder, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Longitudinal StrainDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients on Lurasidone | Patient who are admitted by the psychiatry clinic of our center and meet the inclusion criteria Receives: Diagnostic Test: Global Longitudinal Strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lurasidone molecule will affect left ventricular systolic function
We will measure left ventricular global longitudinal strain of each selected patient before starting to use lurasidone and perform the same evaluation for every patient six months later. Since global longitudinal strain measurement is a preferred way to detect subtle changes of wall motions and contractile functions, we will be able detect if this molecule has any negative effect on left ventricular systolic function.
Measured: All patients whom are admitted by our psychiatry clinic for the next 6 months will be included.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study startNov 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lurasidone CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Gulastı, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695676
- Sponsor's protocol ID
- 2024/164
- Acronym
- Lurasidone
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36765941Alawami 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.
PubMed 25131906Curto 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.
PubMed 27222142
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricle Systolic Functions of Patients On Lurasidone
- ClinicalTrials.gov ID
- NCT06695676
- Acronym / sponsor ID
- Lurasidone / 2024/164
- Keywords
- Global Longitudinal Strain, Cardiotoxicity, Lurasidone, antipsychotic drugs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on Lurasidone | – | Diagnostic Test: Global Longitudinal StrainPatient who are admitted by the psychiatry clinic of our center and meet the inclusion criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who apply to Adnan Menderes University Psychiatry Clinic and meet the criteria of inclusion
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who do not agree to participate to the trial
- Patient who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global Longitudinal StrainGlobal 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. | Diagnostic test | Patients on Lurasidone |
Primary outcome
Lurasidone molecule will affect left ventricular systolic function
Time frame: All patients whom are admitted by our psychiatry clinic for the next 6 months will be included.
We will measure left ventricular global longitudinal strain of each selected patient before starting to use lurasidone and perform the same evaluation for every patient six months later. Since global longitudinal strain measurement is a preferred way to detect subtle changes of wall motions and contractile functions, we will be able detect if this molecule has any negative effect on left ventricular systolic function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 36765941Slawinski 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.
- Background: PubMed 25131906Alawami 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.
- Background: PubMed 27222142Curto 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.
- How and Why to Use Global Longitudinal Strain MeasurementLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lurasidone Cardiotoxicity and Schizophrenia Patients, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevil Gulasti Cardiologist Sevil Gulasti (+905054513277, drsevilonay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lurasidone molecule will affect left ventricular systolic function (time frame: All patients whom are admitted by our psychiatry clinic for the next 6 months will be included.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.