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The Comparison of Aripiprazole versus Risperidone in Attention Disorder Hyperactivity Disorder in Children Under Six Years old age

Protocol summary

Summary
Objectives: The purpose of this study is to evaluate the safety and efficacy of Aripiprazole compare to Risperidone for the treatment of Attention Deficit Hyperactivity disorder in children under 6 years old. Design:randomized, triple blind study, plus placebo Settings and conduct: A child psychiatrist examines 40 children who are referred to child psychiatry clinic of Imam Hosein Hospital. They must fulfill criteria based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) for Attention Deficit Hyperactivity Disorder. Participants: They are 40 children from both gender and three to six years old age. The Inclusion Criteria are children from age three to age six with Attention Deficit Hyperactivity Disorder.They exclude from study if they have any other co morbidity that interferes with diagnosis and treatment like bipolar disorder; psychotic disorder; mental retardation; development delay disorders; Autistic disorder; and epilepsy. The other exclusion criteria are any medical condition, which preclude using medication or continuing medication. They do not have to take any psychotropic medication two weeks before starting the study. Intervention: Consent informant will be obtained from parents. Then children randomly divide into two groups. Group one takes Aripiprazole plus Risperidone placebo and the second group takes Risperidone plus Aripiprazole placebo. The clinician and parents are both blind to treatment. The starting dosage of Risperidone is 0.25 mg daily and it will increase every other week depends on the child response. The starting dosage of Aripiprazole is 1.25 mg daily and titrate upward biweekly based on clinical response. Follow-up measures are the ADHD Rating Scale (ADHD RS), Children-Global Assessment Scale (C-GAS), Conners Rating Scale-Parent (CRSP) and side effect questionnaire. They will assessed for three months at the baseline, week 2, week 4, week eight and week 12. Statistician calculates the results statistically at the end. Main outcome: decreasing Attention Deficit Hyperactivity scores in ADHD Rating Scale (ADHD-RS),Children-Global Assessment Scale (C-GAS), Conners Rating Scale-Parent (CRSP) measures

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013050413215N1
Registration date: 2013-07-31, 1392/05/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-31, 1392/05/09
Registrant information
Name
Katayoon Razjouyan
Name of organization / entity
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 1023
Email address
k_razjouyan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2013-05-31, 1392/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Aripiprazole versus Risperidone in Attention Disorder Hyperactivity Disorder in Children Under Six Years old age
Public title
The Comparison of Aripiprazole versus Risperidone in Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Children from age three to age six with Attention Deficit Hyperactivity Disorder Exclusion Criteria: co-morbidity with Bipolar Disorder; Psychotic Disorder; Mental Retardation;Autistic Disorder;Developmental Delay Disorder; Epilepsy; Any unstable physical conditions that preclude the use of oral medication or continuing treatment process;taking any psychotropic medication in two weeks prior to study.
Age
From 3 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
NA
Secondary trial Id
NA
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2012-02-12, 1390/11/23
Ethics committee reference number
7812

Health conditions studied

1

Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Hyperkinetic disorders

Primary outcomes

1

Description
Attention Deficit Hyperactivity scores
Timepoint
two weeks, four weeks, eight weeks and twelve weeks after intervention
Method of measurement
ADHD-RS, C-GAS, CRSP

Secondary outcomes

1

Description
medication side effects
Timepoint
Second week. Four weeks, eight weeks, twelve weeks after the intervention.
Method of measurement
Side Effect Questionnaire

Intervention groups

1

Description
intervention group: The starting dosage of Aripiprazole is 1.25 mg daily and it will increase 1.25 mg per day every other week depends on the child response. At the same time, they will receive placebo of Risperidone that is similar to one mg tablet. The starting dosage of that is 1/4 of tablet per day. Placebo will titrate upward with 1/4 tablet each time the clinician increase the dosage of Aripiprazole.
Category
Placebo

2

Description
Control group: The starting dosage of Risperidone is 0.25 mg daily and it will increase 0.25 mg per day every other week depends on the child response. At the same time, they will receive placebo of Aripiprazole that is similar to five mg tablet. The starting dosage of that is 1/4 of tablet per day. Placebo will titrate upward with 1/4 tablet each time the clinician increase the dosage of Risperidone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Katayoon Razjouyan, Child and Adolescent Psychiatrist, Assistant Professor of Psychiatry
Street address
Shahid Madani Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Rahmati Rodsari
Street address
Velenjak Str. , Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shahid Beheshti 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
Behavioral Sciences Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Arash Danesh
Position
Residency of Psychiatry
Other areas of specialty/work
Street address
Imam Hosein Hospital, Shahid Madani Street
City
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Fax
+98 77551023
Email
khalildanesh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Behavioral Sciences Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoon Razjouyan
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Imam Hosein Hospital, Shahid Madani Street
City
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Fax
Email
k_razjouyan@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Behavioral Sciences Research center, Shahid Beheshty Medical University of Tehran
Full name of responsible person
Katayoon Razjouyan
Position
Assistant Professor of Child and Adolescent Psychiatry
Other areas of specialty/work
Street address
Imam Hosein Hospital, Shahid Madani St.
City
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Fax
Email
k_razjouyan@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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