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

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ClinicalTrials.gov 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
Information provided by:

Study Description
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.

Study Design

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

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00318162

Contact: David S Wilensky, MD 97227828142 davidvil@012.net.il

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

ClinicalTrials.gov Identifier: NCT00318162     History of Changes
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:
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Autistic Disorder
Neurodevelopmental Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents