Goal of this study is comparison of Duloxetine with Methylphenidate in treatment of attention deficit -hyperactivity disorder. For this purpose, we will include 10 child aged 6-12 years old with attention deficit -hyperactivity disorder who refer to child and adolescent psychiatry clinic. Exclusion criteria is mental retardation and comorbidity of major psychiatric disorders. After written consent we will register their demographic characteristics and apply Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version semi structured interview for diagnosis of attention deficit -hyperactivity disorder and comorbidities. In a 6 weeks open trial , we will prescribe Duloxetine or Methylphenidate to these patients . For evaluating effects of the drugs and their complications , we will use of attention deficit -hyperactivity disorder Rating Scale , Conners Scale-parent and side effect checklist form each two weeks . By Children Depression Inventory and Revised Children's Manifest Anxiety Scale we will compared depressive and anxiety symptoms in beginning and at the end of the trial
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101510363N2
Registration date:2012-11-08, 1391/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-08, 1391/08/18
Registrant information
Name
Nasrin Dodangi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3340 1604
Email address
na.dodangi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-09-20, 1392/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Duloxetine in comparison with Methylphenidate in treatment of children with Attention Deficit/ Hyperactivity Disorder
Public title
Comparison of Duloxetine and Methylphenidate in treatment of children with Attention Deficit/ Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : ADHD diagnosis according to DSM-IV-TR that is applied by two psychiatrists; age between 6-12 years old
Exclusion criteria : mental retardation; history of heart disease; drug sensitivity; comorbidity of severe mental illnesses such as bipolar disorder, major depressive disorder, conduct disorder, psychosis; history of seizure.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar st., Daneshgah st., Velenjak
City
Tehran
Postal code
Approval date
2012-07-24, 1391/05/03
Ethics committee reference number
7188/t/801/91
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder(ADHD)
ICD-10 code
F90.0
ICD-10 code description
Attention deficit: disorder with hyperactivity hyperactivity disorder syndrome with hyperactivity
Primary outcomes
1
Description
severity of ADHD symtoms
Timepoint
each two weeks
Method of measurement
ADHD rating scale/ Conners rating scale-parent form
Secondary outcomes
1
Description
drug side effects, severity of depressive and anxiety symptoms
Timepoint
beginning and end of trial
Method of measurement
checklist of side effects- CDI-RCMAS
Intervention groups
1
Description
In Duloxetine group , we will prescribe this agent for 6 weeks once daily orally at night. The dose is 15 mg/d for the first week and 30 mg/d for the next 3 weeks. If needed , we will increase the dose to 60 mg/d in the last 2 weeks, and if not it will continue in the same dose.
Category
Treatment - Drugs
2
Description
In control group, Methylphenidate ( Ritalin ) will be given 1/2 BD in first week and TDS in second week orally ( one in morning , one in afternoon and one at the evening ). Then patients will evaluate and if needed , the dose will increase.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan & Rofide clinic
Full name of responsible person
Nasrin Dodangi
Street address
Razi psychiatric hospital, Aminabad, Shahrerey
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nasrin Dodangi
Street address
No.14; Shaghayegh alley; Roshanaei st.; Qeitarie
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nasrin Dodangi
Position
child and adolescent psychiatrist/ assistant professor
Other areas of specialty/work
Street address
Razi hospitay; aminabad
City
Tehran
Postal code
Phone
+98 21 3340 1604
Fax
+98 21 3340 1604
Email
na.dodangi@yahoo.com nasrin.dodangi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nasrin Dodangi
Position
child and adolescent psychiatrist
Other areas of specialty/work
Street address
No.14, Shaghayegh alley,Roshanaei st., Qeitarie.
City
Tehran
Postal code
Phone
+98 21 2267 8697
Fax
Email
na.dodangi@uswr.ac.ir / nasrin.dodangi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)