Palmitoylethanolamide as adjunctive treatment of Autism: A double blind and placebo controlled trial

Not Applicable

Recruiting

• Conditions: Childhood autism.; Childhood autism

• Registration Number: IRCT201702171556N96
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria: 1-DSM 5 clinical diagnosis of autistic disorder; 2-children between the ages of 4 and 11 years old; 3- presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone).

Exclusion Criteria

1- Presence of any active medical problem; 2-any other psychiatric diagnosis except for Intellectual disability; 3-history of allergy or intolerance to Risperidone; 4- receiving any psychotropic medications during past two weeks prior to the trial; 5-presence of hepatic disease resulting impairment of liver function or rising hepatic enzymes; 6-history of seizure during the last 6 months.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of Autism. Timepoint: Baseline and weerks 5 and 10. Method of measurement: Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (irritibility subscale) and Childhood autism rating scale(CARS).