Objectives: The gold standard for the main symptoms of children with attention deficit hyperactivity disorder (ADHD) is stimulators. But some patients have not got the suitable therapy due to the drug side effect or not responding. So other anti-depression medicines including bupropion and venlafaxine could be help. The aim of present study is to evaluate the therapeutic effect of bupropion and venlafaxine in children with ADHD.
Method: In this study, 40 children between 7 to 10 years old with ADHD according to the ADHD rating scale IV and psychiatric interview and side effect or not responding to Ritalin are entered to the study. These children are randomly divided into two similar groups’ respects to age, gender and education.
Intervention: First group: The patients will be received ritalin with previous dose beside venlafaxine 0.5 mg to Kg weight during the first week. In the second week, half of the first week ritalin dose beside venlafaxine will be given. Venlafaxine dose of 0.1 mg per kg body weight per week is increased till reach to 1.4 mg per kg body weight in the tenth week. Ritalin is deleted from the third week onwards. For the second group: In the first week of 1.4 mg per kg body weight bupropion (beside previous dose ritalin) is given. In the second week, half of the Ritalin dosage beside 1.91 mg per kg body weight bupropion is given. From the second week, 0.51 mg per kg body weight of bupropion is added every week till received to 6 mg per kg of body weight. Ritalin is deleted from the third week onwards.
The main outcomes: Response to treatment in both groups will be evaluated by Connors Parent Questionnaire, ADHD rating scale IV and Clinical Global Impression Scale before the study, after each two weeks and after completing the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306189175N5
Registration date:2013-07-12, 1392/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-12, 1392/04/21
Registrant information
Name
Lida Jarahi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9262
Email address
jarahil@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2011-12-19, 1390/09/28
Expected recruitment end date
2013-10-20, 1392/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of bupropion and venlafaxine in children with Attention deficit hyperactivity disorder
Public title
Comparison of effect of bupropion and venlafaxine in children with hyperactivity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children with attention deficit hyperactivity disorder between 7 to 10 years old with IQ more than 70 by Rion quiz and have not any psychiatric and neurological problem at interview.
Exclusion criteria: Children with attention deficit hyperactivity disorder lower than 7 years old and more than 10 years old, IQ lower than 70 and any psychiatric and neurological problem at interview.
Age
From 7 years old to 10 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2011-04-06, 1390/01/17
Ethics committee reference number
511/71
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.0, F90
ICD-10 code description
Attention deficit: disorder with hyperactivity, hyperactivity disorder and syndrome with hyperactivity
Primary outcomes
1
Description
Percentage of response to treatment
Timepoint
before the study, after each two weeks and after completing the study
Method of measurement
Connors Parent Questionnaire
2
Description
Percentage of response to treatment
Timepoint
before the study, after each two weeks and after completing the study
Method of measurement
Clinical Global Impression Scale
3
Description
Percentage of response to treatment
Timepoint
before the study, after each two weeks and after completing the study
Method of measurement
Attention deficit hyperactivity disorder rating scale IV
Secondary outcomes
empty
Intervention groups
1
Description
First group: The patients will be received ritalin with previous dose beside venlafaxine 0.5 mg to Kg weight during the first week. In the second week, half of the first week ritalin dose beside venlafaxine will be given. Venlafaxine dose of 0.1 mg per kg body weight per week is increased till reach to 1.4 mg per kg body weight in the tenth week. Ritalin is deleted from the third week onwards.
Category
Treatment - Drugs
2
Description
For the second group: In the first week of 1.4 mg per kg body weight bupropion (beside previous dose ritalin) is given. In the second week, half of the Ritalin dosage beside 1.91 mg per kg body weight bupropion is given. From the second week, 0.51 mg per kg body weight of bupropion is added every week till received to 6 mg per kg of body weight. Ritalin is deleted from the third week onwards.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital
Full name of responsible person
Dr Peiman Hashemian
Street address
Ibn Sina Hospital, Hor Amerli Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Peiman Hashemian
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1888 2926
Fax
Email
hashemianp@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Peiman Hashemian
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1888 2926
Fax
Email
hashemianp@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Peiman Hashemian
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1888 2926
Fax
Email
hashemianp@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)