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

May 11, 2023 updated by: Dr. Debadatta Mohapatra, All India Institute of Medical Sciences, Bhubaneswar

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum Glutathione levels following 6 weeks of intervention in both the arms
Time Frame: 6 weeks
Change in serum Glutathione levels following 6 weeks of intervention in both the arms
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.
Time Frame: 6 weeks
6 weeks
Change in ISAA score following 6 weeks of intervention.
Time Frame: 6 weeks
6 weeks
Change in ABC-C score following 6 weeks of intervention. •
Time Frame: 6 weeks
6 weeks
Adverse events reported in both groups
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

May 2, 2024

Study Completion (Anticipated)

March 2, 2025

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/PG Thesis/2022-23/126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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