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

All India Institute of Medical Sciences, Bhubaneswar

Status: Not yet enrolling

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

Treatments: Drug: Risperidone, Aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05868720

IEC/PG Thesis/2022-23/126

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

42 participants in 2 patient groups

Risperidone group

Experimental group

Treatment:

Drug: Risperidone, Aripiprazole

Aripiprazole group

Experimental group

Treatment:

Drug: Risperidone, Aripiprazole