There are some published case reports that buspirone is effective for treating some symptoms of autism. 40 children and adolescents with autism are allocated to one of the two groups. One group will receive buspirone (up to 20 mg/day) and the other group will receive placebo. Both groups will receive risperidone for 8 weeks. Irritability as the outcome will be assessed using Aberrant Behavior Checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307303930N28
Registration date:2014-04-04, 1393/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-04, 1393/01/15
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 Sceinces
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2013-12-06, 1392/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized double blind placebo controlled clinical trial of buspirone for treating autism spectrum disorders
Public title
A randomized double blind placebo controlled clinical trial of buspirone for treating autism spectrum disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: DSM-IV diagnosis of autism spectrum disorders; both genders; aged 4 to 17 years.
Exclusion Criteria: a psychosis; and active substance abuse or dependency.
Age
From 4 years old to 17 years old
Gender
Both
Phase
2
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2012-12-04, 1391/09/14
Ethics committee reference number
CT-P-91-4704
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 Checklist- irritability subscale
Timepoint
Every 4 weeks
Method of measurement
Interveiw
Secondary outcomes
1
Description
Adverse effects
Timepoint
every 4 weeks
Method of measurement
checklist
Intervention groups
1
Description
risperidone (0.5 to 3 mg/day)+ Placebo
Category
Placebo
2
Description
risperidone (0.5 to 3 mg/day)+ Buspirone (10 to 20 mg/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
Ahmad Ghanizadeh
Street address
Hafez Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Hafez Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Anaheed Ayyobzadeh
Position
Medicine Student
Other areas of specialty/work
Street address
Hafez Hospita
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
anaheed.shirazi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
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
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Anaheed Ayyobzadeh
Position
Student of Medicine
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
anaheed.shirazi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)