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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
Sponsor:
Collaborator:
Jerusalem Institute for Child Development
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00318162
First received: April 25, 2006
Last updated: May 2, 2006
Last verified: April 2006
History of Changes
  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
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:

U.S. FDA Resources

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

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

Inclusion Criteria:

  • Diagnosis of PDD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
autism
PDD
LDN
naltrexone

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Naltrexone
Narcotic Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013