A comparative study on the effectiveness of Risperidone versus Risperidone plus naltrexone in treatment of autistic spectrum disorder in children with 6-12 years old

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201108155280N5

Enrollment

Registered

2013-02-10

Start date

2011-09-11

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Autistic Disorder. Childhood autism

Interventions

Intervention 1: 0.5 to 2mg per day risperidone tablet for 18 week. Intervention 2: naltrexone capsule (25mg) in dosage of 0.5 to 1.5 mg per kg per day for 8 weeks.

Treatment - Drugs

0.5 to 2mg per day risperidone tablet for 18 week.

naltrexone capsule (25mg) in dosage of 0.5 to 1.5 mg per kg per day for 8 weeks.

Eligibility

Sex/Gender

All

Age

4 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- children with 4-12 years old; 2- children with at least one of the autistic spectrum disorder signs; 3- Fill out informative consent sheet in order to include the study. Exclusion criteria: 1- Children with severe medical disorders; 2- The history of severe drug sensitivity to naltrexone or risperidone.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Autism. Timepoint: weeks 0,4,8,10,14,18. Method of measurement: CARS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Fatemeh Moharari

Mashhad university of medical scinces, Ibn-e-sina hospital

mohararif1@mums.ac.ir+98 51 1711 2701

Outcome results

None listed

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