Children with ADHD are frequently diagnosed and treated during elementary school. Atypical antipsychotic drugs have been studied in many disorders including ADHD and behavior disorders of children. Risperidone has been studied more than newer drugs; and studies about other drugs in this group is insufficient especially in preshool children. This study is performed with the aim of comparing safety and efficacy of two drugs, risperidone and aripiprazole in treatment of behavior disorders comorbid with ADHD in preschool children. Children attending child psychiatry clinic which have inclusion criteria in the case of parental acceptance and giving written concent are assigned to the study. They are randomly allocated to two groups and treated with risperidone or aripiprazole. Scores of Conners Rating Scale, parent form, and its subscales, CGI scores, body weight, and serum prolactine and FBS are measured at the beginning of treatment. Then parent Conners Scale scores and CGI score measurement and side effect assessment are performed in weeks 2, 4, and 8; and weight and laboratory measurements are repeated in week 8.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041211983N2
Registration date:2014-06-29, 1393/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-29, 1393/04/08
Registrant information
Name
Parvin Safavi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
safavip@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Mciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing response to risperidone and aripiprazol in preschool children with disruptive behavior disorders and ADHD: a randomized controlled trial
Public title
Comparing risperidone and aripiprazole in ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age of 3 to 6 years; affected with disruptive behavior disorders and ADHD based on DSM-IV criteria.
Exclusion criteria : mental retardation or other developmental disorders such as autism; chronic physical or neurologic diseases; treatment with other psychotropic medications; development of severe and untolerable medication side effects .
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:
40
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
Shahrekord University of Medical Sciences
Street address
Kashani street, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Approval date
2013-09-24, 1392/07/02
Ethics committee reference number
92-6-18
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
severity of ADHD and ODD symptoms
Timepoint
weeks 0, 2 , 4, and 8
Method of measurement
Short and Revised version of Conners Rating Scale parent form
2
Description
rate of improvement
Timepoint
weeks 2, 4 and 8
Method of measurement
CGI-I scale
Secondary outcomes
1
Description
drug side effects
Timepoint
weeks 2, 4 and 8
Method of measurement
checklist
2
Description
level of prolactine and fasting blood sugar
Timepoint
weeks 0 and 8
Method of measurement
lab data
3
Description
body weight
Timepoint
weeks 0 and 8
Method of measurement
weight measurement
Intervention groups
1
Description
In the first group oral risperidone with the dose of 0.25 mg once daily is started and and increased by 0.25 mg weekly up to 2 mg per day.
Category
Treatment - Drugs
2
Description
In the second group aripiprazole is started with the dose of 1.25 mg and increased by 1.25 mg weekly up to 10 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali clinic, Shahrekord University of Medical Sciences
Full name of responsible person
Dr Parvin Safavi
Street address
Shahrekord , Emam Ali clinic
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Parvin Safavi
Position
child psychiatrist
Other areas of specialty/work
Street address
Shahrekord , Emam Ali clinic
City
Shahrekord
Postal code
Phone
+98 38 1224 1900
Fax
Email
safavi_p@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Parvin Safavi
Position
child psychiatry
Other areas of specialty/work
Street address
Emam Ali clinic, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1224 1900
Fax
Email
safavi_p@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Parvin Safavi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)