Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-28 @ 10:51 AM
Study NCT ID:
NCT06799559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Safety of QLM1016 in Schizophrenia
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 402}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score', 'timeFrame': 'Time Frame: 6 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female subjects, ages 18-65 inclusive, with a clinical diagnosis of schizophrenia\n* PANSS total score ≥ 70 and ≤ 120，Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behavior, conceptual disorganization, and unusual thought content\n* CGI-S score ≥ 4\n\nExclusion Criteria:\n\n* Currently, meet DSM-5 diagnostic criteria for other psychiatric disorders ( for example schizoaffective disorder, schizophreniform disorder, bipolar I and II disorder; pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders；\n* known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study'}, 'identificationModule': {'nctId': 'NCT06799559', 'briefTitle': 'Study on the Efficacy and Safety of QLM1016 in Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel Controlled Study on the Efficacy and Safety of QLM1016 in the Treatment of Schizophrenia', 'orgStudyIdInfo': {'id': 'QLM1016-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLM1016', 'interventionNames': ['Drug: 3-6mg QLM1016']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aripiprazole oral solution film', 'interventionNames': ['Drug: 10-20 mg Aripiprazole oral solution film']}], 'interventions': [{'name': '3-6mg QLM1016', 'type': 'DRUG', 'description': '3-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks', 'armGroupLabels': ['QLM1016']}, {'name': '10-20 mg Aripiprazole oral solution film', 'type': 'DRUG', 'description': '10-20mg Aripiprazole oral solution film plus QLM1016 dummy oral solution film administered orally once daily for 6 weeks.', 'armGroupLabels': ['Aripiprazole oral solution film']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}