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

Phase 4

Recruiting

• Conditions: Autism Spectrum Disorder; F03.625.164

• Registration Number: RBR-54j3726
• Lead Sponsor: Hospital de Clínicas de Porto Alegre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-29
• Last Update Posted: 29 May 2023
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified