Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05868720
Status:
UNKNOWN
Last Update Posted:
2023-05-22
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000068180', 'term': 'Aripiprazole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum Glutathione levels following 6 weeks of intervention in both the arms', 'timeFrame': '6 weeks', 'description': 'Change in serum Glutathione levels following 6 weeks of intervention in both the arms'}], 'secondaryOutcomes': [{'measure': 'Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.', 'timeFrame': '6 weeks'}, {'measure': 'Change in ISAA score following 6 weeks of intervention.', 'timeFrame': '6 weeks'}, {'measure': 'Change in ABC-C score following 6 weeks of intervention. •', 'timeFrame': '6 weeks'}, {'measure': 'Adverse events reported in both groups', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level']}, 'referencesModule': {'references': [{'pmid': '32206584', 'type': 'RESULT', 'citation': 'Hodges H, Fealko C, Soares N. Autism spectrum disorder: definition, epidemiology, causes, and clinical evaluation. Transl Pediatr. 2020 Feb;9(Suppl 1):S55-S65. doi: 10.21037/tp.2019.09.09.'}, {'pmid': '35804408', 'type': 'RESULT', 'citation': 'Salari N, Rasoulpoor S, Rasoulpoor S, Shohaimi S, Jafarpour S, Abdoli N, Khaledi-Paveh B, Mohammadi M. The global prevalence of autism spectrum disorder: a comprehensive systematic review and meta-analysis. Ital J Pediatr. 2022 Jul 8;48(1):112. doi: 10.1186/s13052-022-01310-w.'}, {'pmid': '17620483', 'type': 'RESULT', 'citation': 'Minshew NJ, Williams DL. The new neurobiology of autism: cortex, connectivity, and neuronal organization. Arch Neurol. 2007 Jul;64(7):945-50. doi: 10.1001/archneur.64.7.945.'}, {'pmid': '23123357', 'type': 'RESULT', 'citation': 'Pandya CD, Howell KR, Pillai A. Antioxidants as potential therapeutics for neuropsychiatric disorders. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Oct 1;46:214-23. doi: 10.1016/j.pnpbp.2012.10.017. Epub 2012 Nov 2.'}, {'pmid': '24669208', 'type': 'RESULT', 'citation': 'Salim S. Oxidative stress and psychological disorders. Curr Neuropharmacol. 2014 Mar;12(2):140-7. doi: 10.2174/1570159X11666131120230309.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this Randomized Controlled Trial is to to compare the effect of Risperidone vs Aripiprazole in terms of change in serum Glutathione level in patients with Autism Spectrum Disorder over a period of 6 weeks.\n\nThe main questions it aims to answer are:\n\n1. (Primary Outcome) Change in serum Glutathione levels following 6 weeks of intervention in both the arms\n2. (Secondary Outcomes) Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.\n\nChange in ISAA score following 6 weeks of intervention. Change in ABC-C score following 6 weeks of intervention. • Adverse events reported in both groups\n\nDetails of intervention- One arm of the study population to get Risperidone 1mg/day for a total duration of 6 weeks and another arm to get Aripiprazole 2mg/day for a total duration of 6 weeks. Baseline assessment of Serum Glutathione, Serum SOD, ISAA scale, ABC-C scale will be done and same will be assesssed at 6 weeks follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria:\n\n * Patients diagnosed with Autism Spectrum Disorder (according to ICD-11 DCR) under the age group of 18 years.\n * Legally authorized representative (LAR) giving voluntary written consent for participation in the study.\n\nExclusion Criteria:\n\n* History of ADHD\n\n * History of any major genetic disorder/ storage disorder/ any special syndromes.\n * History of seizure disorder or any major medical or surgical disorders\n * Legally authorized representative (LAR) not giving voluntary written consent for participation in the study.'}, 'identificationModule': {'nctId': 'NCT05868720', 'acronym': 'versus', 'briefTitle': 'EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences, Bhubaneswar'}, 'officialTitle': 'EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL', 'orgStudyIdInfo': {'id': 'IEC/PG Thesis/2022-23/126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risperidone group', 'interventionNames': ['Drug: Risperidone, Aripiprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole group', 'interventionNames': ['Drug: Risperidone, Aripiprazole']}], 'interventions': [{'name': 'Risperidone, Aripiprazole', 'type': 'DRUG', 'description': 'The patients who are randomized to Risperidone group will receive Risperidone at a dose of 1mg/day during the study period that is for 6 weeks. The patients who are randomized to Aripiprazole group will receive Aripiprazole at a dose of 2mg/day during the study period that is for 6 weeks.', 'armGroupLabels': ['Aripiprazole group', 'Risperidone group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Debadatta Mohapatra, MD', 'role': 'CONTACT', 'email': 'psych_debadatta@aiimsbhubaneswar.edu.in', 'phone': '9437658251', 'phoneExt': '+91'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences, Bhubaneswar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Debadatta Mohapatra', 'investigatorAffiliation': 'All India Institute of Medical Sciences, Bhubaneswar'}}}}