24 child with known PKU aged between 2 to 16 yrs-old that suffer from problem behavior treated cross-overally with risperidone and buspirone for 8-weeks and their therapeutic responses rated with NISONGER child behavior rating form(mental retarded child version) and clinical global improvement(CGI)form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011412131N1
Registration date:2013-05-06, 1392/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-06, 1392/02/16
Registrant information
Name
Abdi Ghajarpour
Name of organization / entity
Hamedan University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 0107
Email address
a.ghajarpour@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Scienses resarch and technology adjutancy
Expected recruitment start date
2012-04-17, 1391/01/29
Expected recruitment end date
2013-05-26, 1392/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluaqtion and comparison of therapeutic effects of risperidone and buspirone in treating problem behaviours in children with phenylketonuria
Public title
Evaluation of risperidone and buspirone in treatment of problem behaviors in children with pku
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: known case of PKU aged 2 to 16 yrs-old that pediatric psychiatrist comment drug therapy for problem behavior and parents documented consent form. Exclusion criteria: serious drug side effects; need to another psychotropic drug; known hypersensitivity to risperidone and buspirone and no clinical benefit of risperidone and buspirone in the past.
Age
From 2 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Besat hospital
City
Hamedan
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
د-پ-16-35-9-1827
Health conditions studied
1
Description of health condition studied
phenylketonuria
ICD-10 code
E70.0
ICD-10 code description
Disorders of aromatic amino-acid metabolism
Primary outcomes
1
Description
compliant/calm
Timepoint
2 month
Method of measurement
NISONGER child behaviour rating form
2
Description
Conduct problem
Timepoint
2 month
Method of measurement
NISONGER child behavior rating form
3
Description
Insecure/Anxious
Timepoint
2 month
Method of measurement
NISONGER child behaviour rating form
4
Description
Overly sensitive
Timepoint
2 month
Method of measurement
NISONGER child behaviour rating form
5
Description
Hyperactive
Timepoint
2 month
Method of measurement
NISONGER child behaviour rating form
6
Description
Self-injury/stereotypic
Timepoint
2 month
Method of measurement
NISONGER child behaviour rating form
7
Description
Self-isolated/Ritualistic
Timepoint
2 month
Method of measurement
NISONGER child behaviour rating form
8
Description
Adaptive/social
Timepoint
2 month
Method of measurement
NISONGER child behaviour rating form
Secondary outcomes
1
Description
Clinical global improvement rate
Timepoint
2 and 4 months
Method of measurement
Clinical global improvement form
Intervention groups
1
Description
Control group includes 13 child with pku between ages 2 to 16 yrs-old that recieve risperidone with gradually increasing doses up to1.5 mg ( and over 30-kg weight with 3 mg) per day for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group include 13 child with phenylketonuria between 2 to 16 yrs -old that recieve buspirone with dose of 2.5mg up to7.5 mg (over 30-kg weight up to 15mg) per day for 8weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Dr Abdi Ghajarpour
Street address
Besat hospital
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
hamedan university of medical sciences
Full name of responsible person
Dr heydar tavilani
Street address
shahid fahmide blu.
City
hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Abdi Ghajarpour
Position
MD, Resident of pediatric
Other areas of specialty/work
Street address
Besat hospital
City
Hamedan
Postal code
371004103
Phone
+98 81 1835 0107
Fax
+98 81 1835 0107
Email
A.ghajarpour@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Afshin Fayyazi
Position
Associate professor of pediatric neurology
Other areas of specialty/work
Street address
Besat hospital
City
Hamedan
Postal code
65-148-45411
Phone
+98 81 1835 0107
Fax
Email
afshin_fay@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Abdi Ghajarpour
Position
MD, Resident of pediatric
Other areas of specialty/work
Street address
Besat hospital
City
Hamedan
Postal code
371004103
Phone
+98 81 1835 0107
Fax
+98 81 1835 0107
Email
A.ghajarpour@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)