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

NCT ID: NCT00318162

Last Updated: 2006-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pervasive Developmental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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low dose naltrexone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PDD
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jerusalem Institute for Child Development

UNKNOWN

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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David S Wilensky, MD

Role: PRINCIPAL_INVESTIGATOR

Jerusalem Institute for Child Development

Locations

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Jerusalem Institute for Child Development

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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David S Wilensky, MD

Role: CONTACT

[email protected]
97227828142

Other Identifiers

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PDDLDN-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id