COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318162
Recruitment Status : Unknown
Verified April 2006 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : April 26, 2006
Last Update Posted : May 3, 2006
Jerusalem Institute for Child Development
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pervasive Developmental Disorder Drug: low dose naltrexone Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD

Primary Outcome Measures :
  1. play observation
  2. Autism Behavior Checklist (ABC) questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of PDD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00318162

Layout table for location contacts
Contact: David S Wilensky, MD 97227828142

Layout table for location information
Jerusalem Institute for Child Development
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Jerusalem Institute for Child Development
Layout table for investigator information
Principal Investigator: David S Wilensky, MD Jerusalem Institute for Child Development
Layout table for additonal information Identifier: NCT00318162    
Other Study ID Numbers: PDDLDN-HMO-CTIL
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: April 2006
Keywords provided by Hadassah Medical Organization:
Additional relevant MeSH terms:
Layout table for MeSH terms
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents