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The Comparison Effects of Risperidone and Aripiprazole on Irritability Symptoms and Serotonin Levels in Children with Autism Spectrum Disorder

The Comparison Effects of Risperidone and Aripiprazole on Irritability Symptoms and Serotonin Levels in Children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250217004
Enrollment
22
Registered
2025-02-17
Start date
2022-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder Autism Spectrum Disorder, Irritability, Serotonin, Risperidone, Aripiprazole

Interventions

patients who met the inclusion criteria and received Risperidone therapy at a dose of 0.02-0.06 mg/ kgBW/ day.,patients who meet the inclusion criteria and receive Aripiprazole therapy with an initial
Experimental Drug,Active Comparator Drug
Treatment Group,control Grup

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
5 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with ASD according to DSM-5. 2. Patients aged 5 to 17 years. 3. Receiving Risperidone therapy with a dosage range of 0.02 to 0.06 mg/kg/day. 4. Receiving Aripiprazole therapy with an initial dose of 0.3 to 0.6 mg/kg/day. 5. Not using any antipsychotic agents other than Risperidone and Aripiprazole prior to the study. 6. ABC-I score more than 18. 7. Parents agree to sign the informed consent form and comply with the testing requirements.

Exclusion criteria

Exclusion criteria: Subjects were excluded from the study if they had other physical illnesses (cardiovascular, endocrine and metabolic, immunosufficiency, and infections), and/or had comorbid psychiatric illnesses (schizophrenia, psychotic disorders, and epilepsy).

Design outcomes

Primary

MeasureTime frame
THE COMPARISON EFFECTS OF RISPERIDONE AND ARIPIPRAZOLE ON IRRITABILITY SYMPTOMS AND SEROTONIN LEVELS IN CHILDREN WITH AUTISM SPECTRUM DISORDER at baseline, week 4, and week 8 of therapy. Numeric was evaluated using the Aberrant Behavior Checklist - Irritability (ABC-I) score

Secondary

MeasureTime frame
IRRITABILITY SYMPTOMS at baseline, week 4, and week 8 of therapy. Numeric was evaluated using the Aberrant Behavior Checklist - Irritability (ABC-I) score

Countries

Indonesia

Contacts

Public ContactRohmatyah Suaib

Faculty of Medicine Hasanuddin University

rohmatyahsuaib@gmail.com081340222240

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026