Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-23 @ 2:11 AM
Study NCT ID:
NCT02013232
Status:
UNKNOWN
Last Update Posted:
2013-12-17
First Post:
2013-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia
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': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-11', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'extrapyramidal symptoms', 'timeFrame': 'baseline, 4 weeks, 8 weeks', 'description': 'assess the extrapyramidal symptoms'}], 'primaryOutcomes': [{'measure': 'Prolactin level', 'timeFrame': 'baseline, 2 weeks, 4 weeks, 8 weeks', 'description': 'Change from baseline in the levels of prolactin'}], 'secondaryOutcomes': [{'measure': 'PANSS (positive and negative syndrome scale) score', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change from baseline in PANSS score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Risperidone;', 'Aripiprazole;', 'Hyperprolactinemia;', 'dose effects'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;\n2. having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;\n3. being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.\n\nExclusion Criteria:\n\n1. any other major psychiatric disorder;\n2. significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation'}, 'identificationModule': {'nctId': 'NCT02013232', 'briefTitle': 'Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing HuiLongGuan Hospital'}, 'officialTitle': 'Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study', 'orgStudyIdInfo': {'id': 'ARI201206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'risperidone plus placebo'}, {'type': 'EXPERIMENTAL', 'label': 'aripiprazole 5mg', 'description': 'risperidone treatment plus aripiprazole 5mg/day', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'EXPERIMENTAL', 'label': 'aripiprazole 10mg', 'description': 'risperidone plus aripiprazole 10mg/day', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'EXPERIMENTAL', 'label': 'aripiprazole 20mg', 'description': 'risperidone plus aripiprazole 20mg/day', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'armGroupLabels': ['aripiprazole 10mg', 'aripiprazole 20mg', 'aripiprazole 5mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102208', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingxu Chen', 'role': 'CONTACT', 'email': 'chenjx1110@163.com', 'phone': '86-13681394260'}, {'name': 'Jingxu Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing HuiLongGuan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jingxu Chen, master', 'role': 'CONTACT', 'email': 'chenjx1110@163.com', 'phone': '86-13681394260'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing HuiLongGuan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Jingxu Chen', 'investigatorAffiliation': 'Beijing HuiLongGuan Hospital'}}}}