The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione LevelversusNCT05868720
EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
A study testing Risperidone, Aripiprazole in people with The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level, run by All India Institute of Medical Sciences, Bhubaneswar.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level
- What is being tested?
- Risperidone, Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 2 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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:
Read more
- (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.
- Being tested
- Risperidone, Aripiprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone, AripiprazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Risperidone group | Experimental | Not described Receives: Drug: Risperidone, Aripiprazole |
| Aripiprazole group | Experimental | Not described Receives: Drug: Risperidone, Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Glutathione levels following 6 weeks of intervention in both the arms
Change in serum Glutathione levels following 6 weeks of intervention in both the arms
Measured: 6 weeks
Secondary outcomes (4)
Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.
Measured: 6 weeks
Change in ISAA score following 6 weeks of intervention.
Measured: 6 weeks
Change in ABC-C score following 6 weeks of intervention. •
Measured: 6 weeks
Adverse events reported in both groups
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion2 May 2024 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Debadatta Mohapatra, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868720
- Sponsor's protocol ID
- IEC/PG Thesis/2022-23/126
- Acronym
- versus
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32206584Salari 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.
PubMed 35804408Minshew 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.
PubMed 17620483Pandya 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.
PubMed 23123357Salim S. Oxidative stress and psychological disorders. Curr Neuropharmacol. 2014 Mar;12(2):140-7. doi: 10.2174/1570159X11666131120230309.
PubMed 24669208
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF RISPERIDONE vs ARIPIPRAZOLE ON OXIDATIVE STRESS IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05868720
- Acronym / sponsor ID
- versus / IEC/PG Thesis/2022-23/126
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 2 May 2024 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone group | Experimental | Drug: Risperidone, Aripiprazole |
| Aripiprazole group | Experimental | Drug: Risperidone, Aripiprazole |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (4 listed)
- History of ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone, AripiprazoleThe 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. | Drug | Aripiprazole group, Risperidone group |
Primary outcome
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
4 secondary outcomes
Change in serum superoxide dismutase (SOD) levels following 6 weeks of intervention.
Time frame: 6 weeks
Change in ISAA score following 6 weeks of intervention.
Time frame: 6 weeks
Change in ABC-C score following 6 weeks of intervention. •
Time frame: 6 weeks
Adverse events reported in both groups
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Results publication: PubMed 32206584Hodges 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.
- Results publication: PubMed 35804408Salari 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.
- Results publication: PubMed 17620483Minshew 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.
- Results publication: PubMed 23123357Pandya 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.
- Results publication: PubMed 24669208Salim S. Oxidative stress and psychological disorders. Curr Neuropharmacol. 2014 Mar;12(2):140-7. doi: 10.2174/1570159X11666131120230309.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone, Aripiprazole in people with The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level, run by All India Institute of Medical Sciences, Bhubaneswar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debadatta Mohapatra, MD (9437658251 ext. +91, psych_debadatta@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum Glutathione levels following 6 weeks of intervention in both the arms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868720, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.