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The effect of ondansetron on autism

Effect of ondansetron combination therapy with risperidone in children with autism spectrum disorder in a randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200317046801N2
Enrollment
40
Registered
2020-04-13
Start date
2020-09-11
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Autism Spectrum Disorder. Autistic disorder

Interventions

Intervention 1: Intervention group: Patients with autism disorder will be treated with combination of risperidone with ondansetron for 8 weeks. Over 40kg and in case of ondansetron is 05 mg / kg / day

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:1-Having criteria for diagnosing autism spectrum disorder based on DSM-5 clinical interview and semi-structured K-SADS interview -. 6 -15years old -To participate in the study with the written consent of the patient's guardian and with the patient's consent

Exclusion criteria

Exclusion criteria: Any active physical illness There is a psychiatric diagnosis other than mental retardation - taking any medication affecting mental status other than risperidone at least two weeks prior to the study, A history of ondansetron allergy Liver or heart disease or neurological or associated kidney disease Causing any drug side effects The patient's or guardian's unwillingness to continue to be involved in the research project for any reason

Design outcomes

Primary

MeasureTime frame
Symptoms of Autism Spectrum Disorder. Timepoint: Baseline and weeks 4and 8. Method of measurement: Childhood Autism Rating Scale (CARS).;Relationship and Behavior. Timepoint: Baseline and weeks 4and 8. Method of measurement: Aberrant Behavior Checklist-Community (ABC-C).;Self-concept. Timepoint: Baseline and weeks 4and 8. Method of measurement: Self- Conception Questionnaire.;Psychiatric diagnosis of autism disorder. Timepoint: Baseline and weeks 4and 8. Method of measurement: kiddie-sads-present and lifetime version (k-sads-pl).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRshim Badrfam

Tehran University of Medical Sciences

rbadrfam@gmail.com+98 21 5541 9151

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026