Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
1 other identifier
interventional
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 26, 2020
June 1, 2020
1.7 years
June 22, 2020
August 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac QTc(corrected QT interval) interphase changes after drug administration.
Cardiac QTc interphase changes during the study duration
baseline, week2,4, 8, 12，24
Secondary Outcomes (5)
Biochemical index： BNP(Brain Natriuretic Peptide)
baseline, week2,4, 8, 12，24
Biochemical index：troponin
baseline, week2,4, 8, 12，24
Biochemical index： myoglobin
baseline, week2,4, 8, 12，24
Electrocardiogram：Heart rate
baseline, week2,4, 8, 12，24
Echocardiographic: EF(Ejection Fraction) value
baseline, week2,4, 8, 12，24
Study Arms (5)
Risperidone
EXPERIMENTALRisperidone tablet
Aripiprazole
EXPERIMENTALAripiprazole tablet
Ziprasidone
EXPERIMENTALZiprasidone tablet
Amisulpride
EXPERIMENTALAmisulpride tablet
Quetiapine
EXPERIMENTALQuetiapine tablet
Interventions
Eligibility Criteria
You may qualify if:
- Phase one:Effects of different types of atypical antipsychotics on cardiac safety.
- 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
- Han ethnic, 18-45 years old;
- Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.
- Willing to participate in the trial and receive treatment;
- Course of disease within 2 years;
- Able to communicate effectively with the researcher and complete the written informed consent signed by hand.
- Phase two:Construction of cardiac safety monitoring model
- 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
- Han ethnic, 18-45 years old;
- Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.
- Willing to participate in the trial and receive treatment;
- Serious arrhythmia, myocarditis, cardiomyopathy and cardiac insufficiency during taking medicine;
- Able to communicate effectively with the researcher and complete the written informed consent signed by hand.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHINA
Shanghai, Minhang, 201108, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LV QINYU
SHANGHAI MENTAL HEALTH CENTRE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 24, 2020
Study Start
May 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
August 26, 2020
Record last verified: 2020-06