In this trial 5 children with autistic disorder who will be outpatients from psychiatric clinics after obtaining informed consent from caregivers will be recruited(the diagnosis of autism based on psychiatric interview and Autistic Diagnostic Interview – R). patients will be treated with aripiprazole for 8 weeks. The dose of aripiprazole will be titrated up to 10 mg/day.Patients will be assessed at baseline and after 2, 4, 6 and 8 weeks. The measure of the outcome will be the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale and CGI-S. side effects will be assessed with side effect checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209309645N2
Registration date:2012-10-29, 1391/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-29, 1391/08/08
Registrant information
Name
Nastaran Habibi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21334012209
Email address
na.habibi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An open – label study of Aripiprazole in the treatment of irritability in children with autistic disorder
Public title
Efficacy of aripiprazole in the treatment of autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical diagnosis of autism; ages 3-6 years
Exclusion criteria: use of antidepressants or antipsychotics one week before trial (fluoxetine 1 month before trial); use of psychostimulants or benzodiazepines 72 hours before trial; severe medical diseases; current diagnosis of bipolar disorder, psychosis,schizophrenia, major depression
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
Approval date
2012-07-28, 1391/05/07
Ethics committee reference number
7299/ت/801/91
Health conditions studied
1
Description of health condition studied
Autistic disorder
ICD-10 code
F84.0
ICD-10 code description
Chilhood autism
Primary outcomes
1
Description
severity of irritability
Timepoint
every two weeks
Method of measurement
The Aberrant Behavior Checklist (ABC
Secondary outcomes
1
Description
extrapyramidal side effects
Timepoint
every two weeks
Method of measurement
Simpson-Angus Scale,the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale
2
Description
other side effects
Timepoint
every two weeks
Method of measurement
side effect checklist
3
Description
Clinical Global Impression–Improvement (CGI-I)
Timepoint
every two weeks
Method of measurement
Clinical Global Impression–Improvement (CGI-I)
Intervention groups
1
Description
aripiprazole 0.5 - 10 mg per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavn rehabilitation clinic
Full name of responsible person
Nastaran Habibi
Street address
Valiasr Avn., Monirieh Sq.
City
Tehran
2
Recruitment center
Name of recruitment center
Rofeydeh rehabilitation clinic
Full name of responsible person
Nastaran Habibi
Street address
Balooch St., Andarzgoo Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Position
Child and adolescent psychiatrist/ assisstant professor
Other areas of specialty/work
Street address
Rastegar Blvd., Rey, Razi Psychiatric Hospital
City
Tehran
Postal code
Phone
+98 21 3340 1220
Fax
Email
dr_nhabibi@yahoo.com na.habibi@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Position
Child and adolescent psychiatrist/ assisstant professor
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 3340 1220
Fax
Email
dr_nhabibi@yahoo.comna.habibi@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Position
Assisstant professor/child and adolescent psychiatrist
Other areas of specialty/work
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
Phone
+98 21 2218 0083
Fax
Email
na.habibi@uswr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)