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NCT05868720 | Not yet recruiting | The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level

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

All India Institute of Medical Sciences, Bhubaneswar

Information provided by (Responsible Party):

Dr. Debadat Mohapatra

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.

Condition or disease

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

Risperidone, Aripiprazole

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 42 participants
Masking : Double
Primary Purpose : Treatment
Official Title : EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : May 2, 2024
Estimated Study Completion Date : March 2, 2025
Arm Intervention/treatment

Experimental: Risperidone group

Drug: Risperidone, Aripiprazole

Experimental: Aripiprazole group

Drug: Risperidone, Aripiprazole
Ages Eligible for Study: 5 Years to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL

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

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