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

• Status: Not yet recruiting
• Trial end date: 2025-03-02
• Target enrollment: 0
• Participant gender: All

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:

1. (Primary Outcome) Change in serum Glutathione levels following 6 weeks of intervention in both the arms

2. (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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Aripiprazole; Risperidone

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.