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

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, April 2006

Sponsors and Collaborators:	Hadassah Medical Organization Jerusalem Institute for Child Development
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00318162

Purpose

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.

Condition	Intervention	Phase
Pervasive Developmental Disorder	Drug: low dose naltrexone	Phase I Phase II

MedlinePlus related topics: Autism Developmental Disabilities

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

play observation
Autism Behavior Checklist (ABC) questionnaire

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	3 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of PDD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318162

Contacts

Contact: David S Wilensky, MD

97227828142

davidvil@012.net.il

Locations

Israel
Jerusalem Institute for Child Development
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Jerusalem Institute for Child Development

Investigators

Principal Investigator:

David S Wilensky, MD

Jerusalem Institute for Child Development

More Information

Study ID Numbers:	PDDLDN-HMO-CTIL
Study First Received:	April 25, 2006
Last Updated:	May 2, 2006
ClinicalTrials.gov Identifier:	NCT00318162
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

autism
PDD
LDN
naltrexone

Study placed in the following topic categories:

Child Development Disorders, Pervasive
Developmental Disabilities
Mental Disorders

Autistic Disorder
Naltrexone
Mental Disorders Diagnosed in Childhood

Additional relevant MeSH terms:

Pathologic Processes
Disease
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs

Narcotic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009