versus: 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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05868720

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level	Drug: Risperidone, Aripiprazole	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

May 2, 2024

Anticipated Study Completion Date :

Mar 2, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Risperidone group	Drug: Risperidone, 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.
Experimental: Aripiprazole group	Drug: Risperidone, 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.

Arm

Intervention/Treatment

Experimental: Risperidone group

Drug: Risperidone, 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.

Experimental: Aripiprazole group

Drug: Risperidone, Aripiprazole

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

All India Institute of Medical Sciences, Bhubaneswar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Dr. Debadatta Mohapatra, Assistant Professor, All India Institute of Medical Sciences, Bhubaneswar

ClinicalTrials.gov Identifier:

NCT05868720

Other Study ID Numbers:

IEC/PG Thesis/2022-23/126

First Posted:

May 22, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Autism Spectrum Disorder

Risperidone

Aripiprazole

Study Results

No Results Posted as of May 22, 2023