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

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pervasive Developmental Disorder

Treatments: Drug: low dose naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT00318162

PDDLDN-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of PDD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind