Clinical trial NCT05868720: EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
Official title: EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in serum Glutathione levels following 6 weeks of intervention in both the arms
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.
timeFrame: 6 weeks
measure: Change in ISAA score following 6 weeks of intervention.
timeFrame: 6 weeks
measure: Change in ABC-C score following 6 weeks of intervention. •
timeFrame: 6 weeks
measure: Adverse events reported in both groups
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Hodges H, Fealko C, Soares N. Autism spectrum disorder: definition, epidemiology, causes, and clinical evaluation. Transl Pediatr. 2020 Feb;9(Suppl 1):S55-S65. doi: 10.21037/tp.2019.09.09.
citation: Salari N, Rasoulpoor S, Rasoulpoor S, Shohaimi S, Jafarpour S, Abdoli N, Khaledi-Paveh B, Mohammadi M. The global prevalence of autism spectrum disorder: a comprehensive systematic review and meta-analysis. Ital J Pediatr. 2022 Jul 8;48(1):112. doi: 10.1186/s13052-022-01310-w.
citation: Minshew NJ, Williams DL. The new neurobiology of autism: cortex, connectivity, and neuronal organization. Arch Neurol. 2007 Jul;64(7):945-50. doi: 10.1001/archneur.64.7.945.
citation: Pandya CD, Howell KR, Pillai A. Antioxidants as potential therapeutics for neuropsychiatric disorders. Prog Neuropsychopharmacol Biol Psychiatry. 2013 Oct 1;46:214-23. doi: 10.1016/j.pnpbp.2012.10.017. Epub 2012 Nov 2.
citation: Salim S. Oxidative stress and psychological disorders. Curr Neuropharmacol. 2014 Mar;12(2):140-7. doi: 10.2174/1570159X11666131120230309.