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

Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00318162

Enrollment

Registered

2006-04-26

Start date

Unknown

Completion date

Unknown

Last updated

2006-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pervasive Developmental Disorder

Keywords

autism, PDD, LDN, naltrexone

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.

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.

Interventions

DRUGlow dose naltrexone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

3 Years to 6 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of PDD

Design outcomes

Primary

Measure	Time frame
play observation	—
Autism Behavior Checklist (ABC) questionnaire	—

Countries

Israel

Contacts

Primary ContactDavid S Wilensky, MD

davidvil@012.net.il97227828142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026