Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)

Phase 1

• Conditions: Pervasive Developmental Disorder

• Registration Number: NCT00318162
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

This study will examine the effects of low-dose naltrexone (LDN) on children with autistic spectrum disorders. The investigators hope to show a positive effect on social functioning and language.

Detailed Description

Fifty children aged three to six years will be recruited for the study. They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over. Assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.

Study Timeline

• Status Verified: 2006-04
• Study First Submitted: 2006-04-25
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-26
• Last Update Submitted: 2006-05-02
• Last Update Posted: 2006-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of PDD

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
play observation
Autism Behavior Checklist (ABC) questionnaire

Trial Locations

Locations (1)

Jerusalem Institute for Child Development; 🇮🇱 Jerusalem, Israel