search
Back to results

EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL (versus)

Primary Purpose

The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Risperidone, Aripiprazole
Sponsored by
All India Institute of Medical Sciences, Bhubaneswar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria: Patients diagnosed with Autism Spectrum Disorder (according to ICD-11 DCR) under the age group of 18 years. Legally authorized representative (LAR) giving voluntary written consent for participation in the study. Exclusion Criteria: History of ADHD History of any major genetic disorder/ storage disorder/ any special syndromes. History of seizure disorder or any major medical or surgical disorders Legally authorized representative (LAR) not giving voluntary written consent for participation in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Risperidone group

    Aripiprazole group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in serum Glutathione levels following 6 weeks of intervention in both the arms
    Change in serum Glutathione levels following 6 weeks of intervention in both the arms

    Secondary Outcome Measures

    Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.
    Change in ISAA score following 6 weeks of intervention.
    Change in ABC-C score following 6 weeks of intervention. •
    Adverse events reported in both groups

    Full Information

    First Posted
    May 11, 2023
    Last Updated
    May 11, 2023
    Sponsor
    All India Institute of Medical Sciences, Bhubaneswar
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05868720
    Brief Title
    EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
    Acronym
    versus
    Official Title
    EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    May 2, 2024 (Anticipated)
    Study Completion Date
    March 2, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    All India Institute of Medical Sciences, Bhubaneswar

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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. The main questions it aims to answer are: (Primary Outcome) Change in serum Glutathione levels following 6 weeks of intervention in both the arms (Secondary Outcomes) Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention. Change in ISAA score following 6 weeks of intervention. Change in ABC-C score following 6 weeks of intervention. • Adverse events reported in both groups Details 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Risperidone group
    Arm Type
    Experimental
    Arm Title
    Aripiprazole group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone, Aripiprazole
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change in serum Glutathione levels following 6 weeks of intervention in both the arms
    Description
    Change in serum Glutathione levels following 6 weeks of intervention in both the arms
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.
    Time Frame
    6 weeks
    Title
    Change in ISAA score following 6 weeks of intervention.
    Time Frame
    6 weeks
    Title
    Change in ABC-C score following 6 weeks of intervention. •
    Time Frame
    6 weeks
    Title
    Adverse events reported in both groups
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria: Patients diagnosed with Autism Spectrum Disorder (according to ICD-11 DCR) under the age group of 18 years. Legally authorized representative (LAR) giving voluntary written consent for participation in the study. Exclusion Criteria: History of ADHD History of any major genetic disorder/ storage disorder/ any special syndromes. History of seizure disorder or any major medical or surgical disorders Legally authorized representative (LAR) not giving voluntary written consent for participation in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Debadatta Mohapatra, MD
    Phone
    9437658251
    Ext
    +91
    Email
    psych_debadatta@aiimsbhubaneswar.edu.in

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32206584
    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.
    Results Reference
    result
    PubMed Identifier
    35804408
    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.
    Results Reference
    result
    PubMed Identifier
    17620483
    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. Erratum In: Arch Neurol. 2007 Oct;64(10):1464.
    Results Reference
    result
    PubMed Identifier
    23123357
    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.
    Results Reference
    result
    PubMed Identifier
    24669208
    Citation
    Salim S. Oxidative stress and psychological disorders. Curr Neuropharmacol. 2014 Mar;12(2):140-7. doi: 10.2174/1570159X11666131120230309.
    Results Reference
    result
    Links:
    URL
    http://www.rehabcouncil.nic.in/writereaddata/autism.pdf
    Description
    Related Info

    Learn more about this trial

    EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL

    We'll reach out to this number within 24 hrs