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Comparison of Propranolol versus Risperidone in children with Autism Spectrum Disorder

Comparative effectiveness of Propranolol versus Risperidone on core symptoms in children with Autism Spectrum Disorder - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069237
Enrollment
78
Registered
2024-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: Propranolol: Beta adrenergic antagonist. It will be started at the dose of 1 mg per day and will be up titrated to a maximum dose of 1.5 mg per day, and it will be given for a period of

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of autism spectrum disorder confirmed by DSM-5. 2. Age range should be 4-12 years 3. Any gender 4. Caregivers willing to give consent and children (> 7 years old) willing to give assent.

Exclusion criteria

Exclusion criteria: 1. Children with co-morbid psychiatric illness except attention deficit hyperactivity disorder (ADHD) 2. Children with Substance Use Disorders. 3. Children with evidence of organic brain syndrome or moderate to severe intellectual disability. 4. Children with any chronic medical conditions such as epilepsy, diabetes mellitus or on medications for the same. 5. Children with current reactive airway disease, untreated thyroid disease, bradycardia, hypotension, unexplained syncope, current major depression, taking medications that interact with propranolol (e.g., alpha-2 agonists). 6. Children on treatment with propranolol or risperidone in the past. 7. Children with family history of Asthma. 8. Children who are nonverbal from the start.

Design outcomes

Primary

MeasureTime frame
Effect of treatment on social communication and restricted/repetitive behaviors on children with Autism Spectrum DisorderTimepoint: 0,2,4,8,12 weeks

Secondary

MeasureTime frame
Effect of treatment on behavioral and anxiety symptoms of Autism Spectrum Disorder and compare side effect profile of both the drugsTimepoint: 0,2,4,8,12 weeks

Countries

India

Contacts

Public ContactDr. Shivangi Mehta

Government Medical College and Hospital, Sector-32, Chandigarh

shivangi02@gmail.com9855784512

Outcome results

None listed

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