CClinicalTrials.gg
Status unknownNCT00318162Updated May 3, 2006

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

A Phase 1/2 interventional study of low dose naltrexone in Pervasive Developmental Disorder, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2006-05-03.

Sponsored by Hadassah Medical Organization · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2006), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pervasive Developmental Disorder

Keywords

  • autism
  • PDD
  • LDN
  • naltrexone
03

In context

Developmental Disabilities

285 studies on the registry are indexed under Developmental Disabilities; 64 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 199 interventional studies indexed under Developmental Disabilities.

Browse Developmental Disabilities studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of PDD
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
50 participants (estimated)

Interventions

  • Druglow dose naltrexone
06

What researchers measure

Primary outcomes

  1. play observation

  2. Autism Behavior Checklist (ABC) questionnaire

07

Study locations

1 site
  • Jerusalem Institute for Child Development
    Jerusalem, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00318162
Lead sponsor
Hadassah Medical Organization
Collaborators
Jerusalem Institute for Child Development
First posted
Apr 26, 2006
Last update
May 3, 2006

Study contacts

David S Wilensky, MD
Contact
davidvil@012.net.il
97227828142
David S Wilensky, MD
principal investigator · Jerusalem Institute for Child Development
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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