Schizophrenia Clinical Trial
Official title:
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
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.
Status | Not yet recruiting |
Enrollment | 350 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | CHINA | Shanghai | Minhang |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center | Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Biochemical index: BNP(Brain Natriuretic Peptide) | Changes of biochemical indexes during the study duration | baseline, week2,4, 8, 12,24 | |
Secondary | Biochemical index:troponin | Changes of biochemical indexes during the study duration | baseline, week2,4, 8, 12,24 | |
Secondary | Biochemical index: myoglobin | Changes of biochemical indexes during the study duration | baseline, week2,4, 8, 12,24 | |
Secondary | Electrocardiogram:Heart rate | Changes of ECG indicators during the study duration | baseline, week2,4, 8, 12,24 | |
Secondary | Echocardiographic: EF(Ejection Fraction) value | Changes of cardiac ultrasound indicators during the study duration | baseline, week2,4, 8, 12,24 |
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