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

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04446234
Collaborator
Shanghai Jiao Tong University School of Medicine (Other)
350
Enrollment
1
Location
5
Arms
20
Anticipated Duration (Months)
17.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Risperidone

Risperidone tablet

Drug: Risperidone
Use medicine according to patients condition

Experimental: Aripiprazole

Aripiprazole tablet

Drug: Aripiprazole
Use medicine according to patients condition

Experimental: Ziprasidone

Ziprasidone tablet

Drug: Ziprasidone
Use medicine according to patients condition

Experimental: Amisulpride

Amisulpride tablet

Drug: Amisulpride
Use medicine according to patients condition

Experimental: Quetiapine

Quetiapine tablet

Drug: Quetiapine
Use medicine according to patients condition

Outcome Measures

Primary Outcome Measures

  1. Cardiac QTc(corrected QT interval) interphase changes after drug administration. [baseline, week2,4, 8, 12,24]

    Cardiac QTc interphase changes during the study duration

Secondary Outcome Measures

  1. Biochemical index: BNP(Brain Natriuretic Peptide) [baseline, week2,4, 8, 12,24]

    Changes of biochemical indexes during the study duration

  2. Biochemical index:troponin [baseline, week2,4, 8, 12,24]

    Changes of biochemical indexes during the study duration

  3. Biochemical index: myoglobin [baseline, week2,4, 8, 12,24]

    Changes of biochemical indexes during the study duration

  4. Electrocardiogram:Heart rate [baseline, week2,4, 8, 12,24]

    Changes of ECG indicators during the study duration

  5. Echocardiographic: EF(Ejection Fraction) value [baseline, week2,4, 8, 12,24]

    Changes of cardiac ultrasound indicators during the study duration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Phase one:Effects of different types of atypical antipsychotics on cardiac safety.
  1. Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks

  2. Han ethnic, 18-45 years old;

  3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.

  4. Willing to participate in the trial and receive treatment;

  5. Course of disease within 2 years;

  6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand.

Phase two:Construction of cardiac safety monitoring model

  1. Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks

  2. Han ethnic, 18-45 years old;

  3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.

  4. Willing to participate in the trial and receive treatment;

  5. Serious arrhythmia, myocarditis, cardiomyopathy and cardiac insufficiency during taking medicine;

  6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand.

Exclusion Criteria:
  • (1) Participating in other clinical studies; (2) Combination of DSM-IV diagnoses other than schizophrenia; (3) History of heart disease; (4) History of drug abuse in the previous 6 months; (5) Pregnant or in the first three months of lactation; (6) Combination of antipsychotics, mood stabilizers and antidepressants was used in the study.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CHINAShanghaiMinhangChina201108

Sponsors and Collaborators

  • Shanghai Mental Health Center
  • Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: LV QINYU, SHANGHAI MENTAL HEALTH CENTRE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT04446234
Other Study ID Numbers:
  • YG2019QNB07
First Posted:
Jun 24, 2020
Last Update Posted:
Aug 26, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Mental Health Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2020