Trials / Unknown
UnknownNCT00318162
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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Hadassah Medical Organization · Academic / Other
- Sex
- All
- Age
- 3 Years – 6 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | low dose naltrexone |
Timeline
- First posted
- 2006-04-26
- Last updated
- 2006-05-03
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00318162. Inclusion in this directory is not an endorsement.