The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level
Conditions
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: 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.
Interventions
DRUGRisperidone, Aripiprazole
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.
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Glutathione levels following 6 weeks of intervention in both the arms | 6 weeks | Change in serum Glutathione levels following 6 weeks of intervention in both the arms |
Secondary
| Measure | 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 |
Contacts
Primary ContactDebadatta Mohapatra, MD
Outcome results
None listed