The objective of this study is to assess the efficacy ofSimvastatin in the treatment of autism. 40 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 simvastatin (20 mg/day for children below 10 years old and 40 mg/day for children older than 10 ) + 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 (Irritability subscale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602041556N86
Registration date:2016-02-04, 1394/11/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-04, 1394/11/15
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
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Simvastatin added to risperidone in the treatment of Autism: a double blind and placebo controlled trial
Public title
Simvastatin in the treatment of Autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder; children between the ages of 4 and 12 years old; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone).
Exclusion criteria: presence of any active medical problem; any other psychiatric diagnosis except for mild mental retardation; receiving any psychotropic medications during past two weeks prior to the trial; presence of hepatic disease; history of seizure; history of allergy to simvastatin or intolerance of it; neutropenia, anemia or thrombocytopenia and renal disease.
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:
40
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, Ghods St., Keshvarz Blvd.
City
Tehran
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.TUMS.REC.1394.1602
Health conditions studied
1
Description of health condition studied
Autistic Disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Severity of Autism
Timepoint
Baseline and weeks 5 and 10 after beginning of treatment