The Goal of this trial is to assess the efficacy of pentoxifylline in the treatment of autism. Forty children between the ages 3 and 11 years (inclusive) with a DSM IV clinical diagnosis of autism and who will be outpatients from a specialty clinic for children at roozbeh psychiatric Hospital will be recruited. Patients will be randomly allocated to celecoxib + risperidone (Group A) or placebo + risperidone (Group B) for a 10-week. The dose of risperidone was titrated up to 1-3.5 mg/day. The dose of celecoxib was titrated up to 300 mg/day. Patients will be assessed at baseline and after 2, 4, 6, 8 and 10 weeks. The measure of the outcome will be the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (total score).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711091556N2
Registration date:2009-02-12, 1387/11/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-02-12, 1387/11/24
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
2009-02-19, 1387/12/01
Expected recruitment end date
2011-02-19, 1389/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double-blind placebo controlled trial of celecoxib added to risperidone in patients with autistic disorder.
Public title
Celecoxib and Autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Ages 3 to 11 years, clinical diagnosis of autism (the diagnosis of autism based on semi structured interview with the parent), lack of use of psychotropic drugs at least two weeks before trial.
Exclusion Criteria:
Previously received neuroleptics or any psychotropic drug treatment 6 months prior to recruitment or having significant active medical problem; Children with severe or profound mental retardation in whom a definitive diagnosis of autism could not be made;
Any diagnosis of psychiatric disorder in Axis I and II; Any organic disorder.
Age
From 3 years old to 11 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
Tehran University of Medical sciences
Street address
Tehran University of Medical sciences, Keshavarz Blv
City
Tehran
Postal code
Approval date
2009-01-23, 1387/11/04
Ethics committee reference number
8144
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
The Aberrant Behavior Checklist (ABC)
Timepoint
every two weeks
Method of measurement
The Aberrant Behavior Checklist (ABC)
2
Description
Childhood Autism Rating Scale
Timepoint
every two weeks
Method of measurement
Childhood Autism Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Risperidone + Celecoxib 300 mg/day
Category
Treatment - Drugs
2
Description
Control: Risperidone + placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Psychiatric Hospital
Full name of responsible person
Prof. M.R. Mohammadi
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. A. Fotouhi
Street address
Tehran University of Medical Sciences, Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. Of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Postal code
13337
Phone
+98 21555412222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Prof. Shahin akhondzadeh
Position
Prof. Of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital, Tehran University of Medical sciences
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)