Clozapine for Autism Spectrum Disorder patients aged 10 to 18 years with severe behavioral problems that have not responded to previous medications.

Clozapine for the treatment of refractory disruptive behaviors in 10-18 years old patients with Autism Spectrum Disorder: an open-label trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-54j3726

Enrollment

Unknown

Registered

2022-06-29

Start date

2022-04-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Autism Spectrum Disorder

Interventions

This study is an open-label clinical trial of a single intervention arm in which all patients will receive clozapine orally. A convenience sample of patients aged 10–18 years old with confirmed autism

D03.633.300.240.220

Eligibility

Age

10 Years to 18 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Autism Spectrum Disorder; boys and girls aged 10 to 18 years; disruptive behaviors with two failures of antipsychotic treatment; Moderate or greater behavioral problems as measured by a Clinical Global Impression Scale—Severity (CGI-S) score of 4 or higher at screening; involvement of a parent or caregiver able to consistently complete assessments throughout the study.

Exclusion criteria

Exclusion criteria: Clinical disease that contraindicates the use of clozapine; history of serious side effects to clozapine; previous treatment failure to the use of clozapine; pregnancy or breastfeeding; absence of psychosocial support considered enough to follow the study protocol.

Design outcomes

Primary

Measure	Time frame
Improvement in Disruptive Behaviors, assessed by the irritability subscale of the Aberrant Behavior Checklist's score.	—

Secondary

Measure	Time frame
Improvement in Adaptive Behavior assessed by the Vineland Adaptive Behavior Scales Third Edition.	—

Countries

Brazil

Contacts

Public ContactAna Martins

Hospital de Clínicas de Porto Alegre

anamartins@hcpa.edu.br+55513359.8000

Outcome results

None listed

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