Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT04446234
Status:
UNKNOWN
Last Update Posted:
2020-08-26
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'C092292', 'term': 'ziprasidone'}, {'id': 'D000077582', 'term': 'Amisulpride'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac QTc(corrected QT interval) interphase changes after drug administration.', 'timeFrame': 'baseline, week2,4, 8, 12，24', 'description': 'Cardiac QTc interphase changes during the study duration'}], 'secondaryOutcomes': [{'measure': 'Biochemical index： BNP(Brain Natriuretic Peptide)', 'timeFrame': 'baseline, week2,4, 8, 12，24', 'description': 'Changes of biochemical indexes during the study duration'}, {'measure': 'Biochemical index：troponin', 'timeFrame': 'baseline, week2,4, 8, 12，24', 'description': 'Changes of biochemical indexes during the study duration'}, {'measure': 'Biochemical index： myoglobin', 'timeFrame': 'baseline, week2,4, 8, 12，24', 'description': 'Changes of biochemical indexes during the study duration'}, {'measure': 'Electrocardiogram：Heart rate', 'timeFrame': 'baseline, week2,4, 8, 12，24', 'description': 'Changes of ECG indicators during the study duration'}, {'measure': 'Echocardiographic: EF(Ejection Fraction) value', 'timeFrame': 'baseline, week2,4, 8, 12，24', 'description': 'Changes of cardiac ultrasound indicators during the study duration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atypical antipsychotics', 'Cardiac safety', 'Model building'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.\n\nWe 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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Phase one:Effects of different types of atypical antipsychotics on cardiac safety.\n\n 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\n 2. Han ethnic, 18-45 years old;\n 3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.\n 4. Willing to participate in the trial and receive treatment;\n 5. Course of disease within 2 years;\n 6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand.\n\nPhase two:Construction of cardiac safety monitoring model\n\n1. 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\n2. Han ethnic, 18-45 years old;\n3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.\n4. Willing to participate in the trial and receive treatment;\n5. Serious arrhythmia, myocarditis, cardiomyopathy and cardiac insufficiency during taking medicine;\n6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand.\n\nExclusion Criteria:\n\n* (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.'}, 'identificationModule': {'nctId': 'NCT04446234', 'briefTitle': 'Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building', 'orgStudyIdInfo': {'id': 'YG2019QNB07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risperidone', 'description': 'Risperidone tablet', 'interventionNames': ['Drug: Risperidone']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole', 'description': 'Aripiprazole tablet', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Ziprasidone', 'description': 'Ziprasidone tablet', 'interventionNames': ['Drug: Ziprasidone']}, {'type': 'EXPERIMENTAL', 'label': 'Amisulpride', 'description': 'Amisulpride tablet', 'interventionNames': ['Drug: Amisulpride']}, {'type': 'EXPERIMENTAL', 'label': 'Quetiapine', 'description': 'Quetiapine tablet', 'interventionNames': ['Drug: Quetiapine']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'description': 'Use medicine according to patients condition', 'armGroupLabels': ['Risperidone']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'description': 'Use medicine according to patients condition', 'armGroupLabels': ['Aripiprazole']}, {'name': 'Ziprasidone', 'type': 'DRUG', 'description': 'Use medicine according to patients condition', 'armGroupLabels': ['Ziprasidone']}, {'name': 'Amisulpride', 'type': 'DRUG', 'description': 'Use medicine according to patients condition', 'armGroupLabels': ['Amisulpride']}, {'name': 'Quetiapine', 'type': 'DRUG', 'description': 'Use medicine according to patients condition', 'armGroupLabels': ['Quetiapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201108', 'city': 'Shanghai', 'state': 'Minhang', 'country': 'China', 'facility': 'CHINA', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'LV QINYU', 'role': 'CONTACT', 'email': '18616550357@163.com', 'phone': '18017311158'}, {'name': 'YI ZHENGHUI', 'role': 'CONTACT', 'email': 'yizhenghui1971@163.com', 'phone': '18017311007'}], 'overallOfficials': [{'name': 'LV QINYU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SHANGHAI MENTAL HEALTH CENTRE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}