Status:
UNKNOWN
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
Shanghai Jiao Tong University School of Medicine
Conditions:
Schizophrenia
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
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 ...
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 typ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- (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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04446234
Start Date
May 1 2021
End Date
December 31 2022
Last Update
August 26 2020
Active Locations (1)
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1
CHINA
Shanghai, Minhang, China, 201108