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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Risperidone, Aripiprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risperidone group<br> | Drug: Risperidone, Aripiprazole<br>* 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.<br>|
| Experimental: Aripiprazole group<br> | Drug: Risperidone, Aripiprazole<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks | 

Secondary Outcome Measures

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