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

Pervasive Developmental Disorder Clinical Trial

Official title:

Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00318162
• Other study ID #: PDDLDN-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: April 25, 2006
• Last updated: May 2, 2006

Study information

• Verified date: April 2006
• Source: Hadassah Medical Organization
• Contact: David S Wilensky, MD
• Phone: 97227828142
• Email: davidvil[@]012.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PDD

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Pervasive Developmental Disorder

Intervention

Drug:
• low dose naltrexone

Locations

Country	Name	City	State
Israel	Jerusalem Institute for Child Development	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Jerusalem Institute for Child Development

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	play observation
Primary	Autism Behavior Checklist (ABC) questionnaire