Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT04002258
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D006966', 'term': 'Hyperprolactinemia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014150', 'term': 'Antipsychotic Agents'}], 'ancestors': [{'id': 'D014149', 'term': 'Tranquilizing Agents'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10363}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prolactin level at first 1-month antipsychotic treatment', 'timeFrame': 'at first 1-month antipsychotic treatment', 'description': 'Serum prolactin level may change significantly after one month antipsychotic treatment.'}], 'secondaryOutcomes': [{'measure': 'prolactin level at other time points', 'timeFrame': 'after 2-month, 3-month and half a year treatment with antipsychotics', 'description': 'Different patients have different tendencies of prolactin, so collecting prolactin level at different time after exposed to antipsychotics is necessary.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Antipyretics Toxicity', 'Prolactin Excess']}, 'referencesModule': {'references': [{'pmid': '40830714', 'type': 'DERIVED', 'citation': 'Zhang L, Zheng Y, Huang J, Yu W, Zhou L, He L, Li Y, Hu H, Li G, Shen Y, Zhang J, Li H. Patterns of Serum Prolactin Elevation Associated with Nine Second-Generation Antipsychotics in a Large Cohort of Patients with Schizophrenia. CNS Drugs. 2025 Dec;39(12):1317-1330. doi: 10.1007/s40263-025-01216-1. Epub 2025 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nHyperprolactinemia(HPRL) which can result in a series of prolactin-related symptoms is a frequent adverse effect of antipsychotics. The investigators are interested to explicate the characteristics of serum prolactin level change after taking different antipsychotics and related factors.\n\nMethod:\n\n1. Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.\n2. The investigators collect their information, and then\n\n 1. set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.\n 2. Variables will range from antipsychotic kinds, dosage, treatment duration and blood concentration to demographic information, to disease history, to clinical treatment on hyperprolactinemia, to laboratory test results, such as blood routine examination, biochemistry, sex hormone levels and so on.\n 3. After data cleaning and management, we will apply logistic regression, cox regression, Receiver Operating Characteristic curve (ROC) and machine learning to\n\n * analyze factors of prolactin level;\n * establish a model of prolactin change with time;\n * propose optimal monitoring time of prolactin according to prolactin change with time;\n * analyze correlation among antipsychotics, prolactin and clinical characters, for the purpose to supply objective evidence for antipsychotic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with schizophrenia who were taking or going to take antipsychotic medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders(DSM)-5;\n* were taking or going to take antipsychotics;\n* have the results of serum prolactin level.\n\nExclusion Criteria:\n\n* other mental disorder;\n* suffered endocrinic diseases of pituitary or thyroid gland;\n* suffered other organic brain diseases;\n* have the history of tobacco or alcohol abuse, or psychoactive drug substance abuse.'}, 'identificationModule': {'nctId': 'NCT04002258', 'briefTitle': 'Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment', 'orgStudyIdInfo': {'id': 'CRC2018DSJ01-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Antipsychotic', 'type': 'DRUG', 'description': 'any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Huafang Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Clinical Professor', 'investigatorFullName': 'LI, Huafang', 'investigatorAffiliation': 'Shanghai Mental Health Center'}}}}