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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00318162
First Posted: April 26, 2006
Last Update Posted: July 25, 2007
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.
Collaborator:
Jerusalem Institute for Child Development
Information provided by:
Hadassah Medical Organization
  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 1 Phase 2

Study Type: Interventional
Study Design: 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

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.
  Eligibility

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
Criteria

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


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

Locations
Israel
Jerusalem Institute for Child Development Not yet recruiting
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

ClinicalTrials.gov Identifier: NCT00318162     History of Changes
Other Study ID Numbers: PDDLDN-HMO-CTIL
First Submitted: April 25, 2006
First Posted: April 26, 2006
Last Update Posted: July 25, 2007
Last Verified: April 2006

Keywords provided by Hadassah Medical Organization:
autism
PDD
LDN
naltrexone

Additional relevant MeSH terms:
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Autistic Disorder
Neurodevelopmental Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents