Back to results

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

Primary Purpose

Pervasive Developmental Disorder

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

low dose naltrexone

About this trial

This is an interventional treatment trial for Pervasive Developmental Disorder focused on measuring autism, PDD, LDN, naltrexone

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of PDD

Sites / Locations

Jerusalem Institute for Child Development

Outcomes

Primary Outcome Measures

play observation

Autism Behavior Checklist (ABC) questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT00318162

First Posted

April 25, 2006

Last Updated

May 2, 2006

Sponsor

Hadassah Medical Organization

Collaborators

Jerusalem Institute for Child Development

1. Study Identification

Unique Protocol Identification Number

NCT00318162

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2006

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

Collaborators

Jerusalem Institute for Child Development

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pervasive Developmental Disorder

Keywords

autism, PDD, LDN, naltrexone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

low dose naltrexone

Primary Outcome Measure Information:

Title

play observation

Title

Autism Behavior Checklist (ABC) questionnaire

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of PDD

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David S Wilensky, MD

Phone

97227828142

davidvil@012.net.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David S Wilensky, MD

Organizational Affiliation

Jerusalem Institute for Child Development

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jerusalem Institute for Child Development

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs