Title
Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)
Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD
Phase
Phase 1/Phase 2Lead Sponsor
Hebrew UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Pervasive Developmental DisorderIntervention/Treatment
naltrexone ...Study Participants
50This 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.
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.