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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
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   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of PDD
  Contacts and Locations
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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

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Autistic Disorder
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017