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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 25, 2006

Last Updated Date

May 2, 2006

Start Date ^†

Current Primary Outcome Measures ^†

play observation
Autism Behavior Checklist (ABC) questionnaire

Original Primary Outcome Measures ^†

play observation
ABC questionnaire

Change History

Complete list of historical versions of study NCT00318162 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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 Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^†

Pervasive Developmental Disorder

Intervention ^†

Drug: low dose naltrexone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria: - Diagnosis of PDD

Gender

Both

Ages

3 Years to 6 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: David S Wilensky, MD

97227828142

davidvil@012.net.il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00318162

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hadassah Medical Organization

Collaborators ^††

Jerusalem Institute for Child Development

Investigators ^†

Principal Investigator:

David S Wilensky, MD

Jerusalem Institute for Child Development

Information Provided By

Hadassah Medical Organization

Verification Date

April 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.