The objective of this study is to assess the efficacy of palmitoylethanolamide in the treatment of autism. Forty children between the ages 4 and 12 years with a DSM -5 clinical diagnosis of autistic disorder and who will be outpatients from a specialty clinic for children will be recruited. The children should present with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients will be randomly allocated into palmitoylethanolamide (600 mg BID) + Risperidone (1-3.5mg/day) or Placebo + Risperidone (1-3.5mg/day) for a 10-week, double-blind, placebo-controlled study. Patients will be assessed at baseline and after 5 and 10 weeks of starting medication. The primary outcome measure is the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (Irritibilityy subscale) and Childhood autism rating scale(CARS) .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702171556N96
Registration date:2017-02-20, 1395/12/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2019-03-05, 1397/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Palmitoylethanolamide as adjunctive treatment of Autism: A double blind and placebo controlled trial
Public title
Palmitoylethanolamide as adjunctive treatment of Autism: A double blind and placebo controlled trial
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshvarz Blvd.