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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Jerusalem Institute for Child Development
Information provided by:
Hadassah Medical Organization Identifier:
First received: April 25, 2006
Last updated: May 2, 2006
Last verified: April 2006
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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • play observation
  • Autism Behavior Checklist (ABC) questionnaire

Estimated Enrollment: 50
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.

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

Inclusion Criteria:

  • Diagnosis of PDD
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00318162

Contact: David S Wilensky, MD 97227828142

Jerusalem Institute for Child Development Not yet recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Jerusalem Institute for Child Development
Principal Investigator: David S Wilensky, MD Jerusalem Institute for Child Development
  More Information Identifier: NCT00318162     History of Changes
Other Study ID Numbers: PDDLDN-HMO-CTIL 
Study First Received: April 25, 2006
Last Updated: May 2, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Mental Disorders
Neurodevelopmental Disorders
Narcotic Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016