This is a double blind randomized controlled clinical trial comparing the efficacy and safety of aripiperazole (2-15mg/day), or risperidone (0.5-3mg/day) for treatment of children and adolescents with autism spectrum disorders. Diagnoses are made using DSM-IV diagnostic criteria. The study includes at least 50 children and adolescent. The duration of study is 8 weeks. Clinical Global Impression, Severity and Aberrant Behavior Checklist are used to evaluate treatment outcome. Side effects are assessed using a checklist. Assessment is one at baseline, and weeks of 4 and 8.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110233930N15
Registration date:2011-12-12, 1390/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-12, 1390/09/21
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aripiprazole versus risperidone for treatment of autism
Public title
Aripiprazole versus risperidone for treatment of autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: DSM-IV diagnosis of autism spectrum disorders; both genders; being able to eat medication; providing written informed consent. Exclusion Criteria: unstable medical condition; evidence of active liver disease; unstable hypertension or cardiac disease; unstable asthma; and kidney disease as determined by the investigator; subjects who are allergic to the medications; initiation of new behavioral therapy.
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CT-90-3135
Health conditions studied
1
Description of health condition studied
Pervasive developmental disorders
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Abbrant Behavior Checklis
Timepoint
every 4 week
Method of measurement
interview
Secondary outcomes
1
Description
adverse effects
Timepoint
every 4 week
Method of measurement
interview
Intervention groups
1
Description
aripiperazole (2-15mg/day)
Category
Treatment - Drugs
2
Description
risperidone (0.5-3mg/day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Aliakbar Sahraeizadeh
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Hafez Hospital, Chamran street
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)