Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-29 @ 1:29 AM
Study NCT ID:
NCT05169268
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2021-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-life Assessment of Abilify Maintena + Rexult 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'C000591922', 'term': 'brexpiprazole'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2021-11-26', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline score of the Brief Psychiatric Rating Scale-24 at 3rd and 6th months', 'timeFrame': '6 months', 'description': 'Measuring efficacy on positive and negative psychotic symptoms with a total score ranges from 24 (normal) to 168 (severe ill)'}, {'measure': 'Change from baseline score of the Clinical Global Impression Scale at 3rd and 6th months', 'timeFrame': '6 months', 'description': 'measuring efficacy on overall clinical improvement and severity of subjects with a score ranges from 0 (normal) to 18 (severely ill)'}, {'measure': 'Change from baseline score of the Hamilton Anxiety Rating Scale at 3rd and 6th months', 'timeFrame': '6 months', 'description': 'measuring anxiety symptoms of the subjects with a score ranges from 0 (not ill) to 56 (severe)'}, {'measure': 'Change from basline score of the Hamilton Depression Rating Scale at 3rd and 6th months', 'timeFrame': '6 months', 'description': 'measuring depressive symptoms of the subjects with a score ranges from 0 (normal) to 62 (very severe)'}], 'secondaryOutcomes': [{'measure': 'Change from basline score of the Simpson Angus Score at 3rd and 6th months', 'timeFrame': '6 months', 'description': 'for intolerability assessment on extra-pyramidal side effects of the subjects from 0 (not present) to 24 (most severe)'}, {'measure': 'Change from baseline score of the Barnes Akathisia Rating Scale at 3rd and 6th months', 'timeFrame': '6 months', 'description': 'for intolerability assessment on akathisia of the subjects from 0 (not present) to 14 (severe)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Antipsychotics', 'Aripiprazole', 'Brexpiprazole'], 'conditions': ['Schizophrenia and Related Disorders', 'Anxiety Depression']}, 'descriptionModule': {'briefSummary': 'MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorder prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in a real-life clinical setting.', 'detailedDescription': 'Currently, there is no recommendation on next-step treatment strategy if the patients remain suffering from residual symptoms, have incomplete remission, or have acute exacerbation of schizophrenia whilst receiving aripiprazole long acting injection at its recommended (maximum) dose, except to switch to other second generation antipsychotics (SGA) or to clozapine if they are in their treatment-resistant course. Such practice may incur risks of full relapse and/or unnecessary side effects to the patients, in particularly to those already showed insufficient treatment response, intolerability to side effects, or non-adherence to other antipsychotics before. On the contrary, adding another SGAs to this special cohort appears to be rational. Especially, brexpiprazole might be an ideal choice for its serotonin-dopamine activity modulator property to achieve better symptom control, and at the same time retaining the benefits from the lower incidence of side effects than other SGAs.\n\nCases reports on combination therapy with aripiprazole (oral or LAI) with brexpiprazole had demonstrated initial favorable outcomes, albeit lacking empirical evidence from randomized controlled trial or longer term follow-up study. Therefore, the current MainRexult study aims to carefully evaluate a cohort of patients with schizophrenia and related disorders prescribed with the combination therapy with Abilify Maintena and Rexulti on its efficacy and tolerability in an non-interventional, naturalistic real-life clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are diagnosed with schizophrenia and related disorders who are receiving Abilify Maintena and Brexpiprazole as treatment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18- 65 years old at the time of enrollment\n* Able to read and communicate in English and/or Chinese\n* Able to give informed consent\n* Has been diagnosed to have Schizophrenia (DSM-5 or ICD-10 F20 \\[except F20.81\\], Schizotypal (Personality) Disorder (DSM-5 or ICD-10 F21), or Schizoaffective Disorder (DSM-5 or ICD-10 F25), (Persistent) Delusional Disorder (DSM-5 or ICD-10 F22), Schizophreniform Disorder (DSM-5 or ICD-10 F20.81), Brief Psychotic Disorder (DSM-5) or Acute and Transient Psychotic Disorder (ICD-10 F23)\n* Is receiving the combination with Abilify Maintena and brexpiprazole as treatment ≤8 weeks at the time of recruitment\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Unable to read English or Chinese\n* Unable to give informed consent\n* Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73)'}, 'identificationModule': {'nctId': 'NCT05169268', 'acronym': 'MainRexult', 'briefTitle': 'Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Real-life Assessment of Aripiprazole Long-acting Injection (Abilify Maintena) Combined With Brexpiprazole (Rexulti) in Schizophrenia: a Naturalistic Non-interventional Prospective Follow-up Study', 'orgStudyIdInfo': {'id': 'UW-21-734'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MainRexult Group', 'description': 'Subjects with schizophrenia and related disorders receiving Abilify Maintena (aripiprazole 1 monthly depot) together with Rexulti (Brexpiprazole)', 'interventionNames': ['Drug: ARIPiprazole Injection [Abilify]', 'Drug: Brexpiprazole']}], 'interventions': [{'name': 'ARIPiprazole Injection [Abilify]', 'type': 'DRUG', 'otherNames': ['Abilify Maintena'], 'description': 'subject already receiving the combination of Abilify Maintena and Rexulti', 'armGroupLabels': ['MainRexult Group']}, {'name': 'Brexpiprazole', 'type': 'DRUG', 'otherNames': ['Rexulti'], 'description': 'subject already receiving the combination of Abilify Maintena and Rexulti', 'armGroupLabels': ['MainRexult Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000000', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Albert KK Chung', 'role': 'CONTACT', 'email': 'chungkka@hku.hk', 'phone': '2255 3067'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Albert KK Chung, MBBS', 'role': 'CONTACT', 'email': 'chungkka@hku.hk', 'phone': '2255 4486'}], 'overallOfficials': [{'name': 'Albert KK Chung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}