Protocol summary

Study aim
treatment with efficient drugs for the disorder
Design
patient doesn’t know about wich drugs he or she used but because the forms and shapes of drugs are different maybe they would understand the drug differences.Researcher knows which drugs are used for patients.Patients are devided into 2 groups randomly
Settings and conduct
Yahyanejad hospital clinic, Babol University of Medical Sciences. ADHD-RS questionnaire or attention deficit hyper activity disorder rating scale is a questionnaire which has 18 questions used for a measurement of ADHD recovery in different studies.Time for filling out the questionnaire is about 5 minutes.Psychologist asks questions from children and then completes the form of questionnaire and rates the answers.
Participants/Inclusion and exclusion criteria
pediatric outpatients with attention deficit hyperactivity disorder. Inclusion criteria: ADHD disorder(all types)was diagnosed on the base of attention deficit-hyperactivity DSM-V system criteria,pediatric; patients with ADHD diagnosis who were maltreated,patient don’t suffer from hepatic, cardiac,renal or chronic diseases which have required special care;patients haven’t used MAOI drugs during recent 15 days. Exclusion criteria: eating disorders; substance use disorders; psychiatric disorders such as tic, mental ,pervasive developmental disorders,personal or familial history of Tourette syndrome; seizure; history of Hyperthyroidism,glaucoma; using of drugs that are contraindicated with Ritalin or Atomoxetin; patients with history of no response to prior medications of ADHD; occurrence of menstruation in girls.
Intervention groups
Group 1: 30 patients receive Ritalin (Novarits company, Riralin). Group 2: 30 patients receive Atomoxetin(Abidi company, Stramox).
Main outcome variables
ADHD-RS questionnaire

General information

Reason for update
Acronym
ADHD
IRCT registration information
IRCT registration number: IRCT20170606034348N1
Registration date: 2018-03-14, 1396/12/23
Registration timing: retrospective

Last update: 2018-03-14, 1396/12/23
Update count: 0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 121 3171
Email address
a.hamidia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-21, 1395/06/31
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2016-09-21, 1395/06/31
Actual recruitment end date
2017-09-22, 1396/06/31
Trial completion date
empty
Scientific title
Comparison Atomoxetine Versus Ritalin in pediatric outpatients with attention deficit hyperactivity disorder
Public title
Effect of Atomoxetin Versus Ritalin in pediatric outpatients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ADHD disorder (all types) was diagnosed on the base of attention deficit-hyperactivity DSM-V system criteria. patients with ADHD diagnosis who were maltreated cardiac, renal or chronic diseases which have required special care. patients haven’t used MAOI drugs during recent 15 days
Exclusion criteria:
Exclusion criteria: eating disorders; substance use disorders; psychiatric disorders such as tic, mental, pervasive developmental disorders,personal or familial history of Turette syndrome; seizure; history of Hyperthyroidism, glaucoma; using of drugs that are contraindicated with Ritalin or tomoxetin; patients with history of no response to prior medications of ADHD; occurrence of menstruation in girls.
Age
From 6 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
randomly
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
کمیته اخلاق پزشکی علوم پزشکی بابل
Street address
Babol University of Medical Sciences,Ganjafrooz street
City
Babol
Province
Mazandaran
Postal code
45745-47176
Approval date
2016-02-28, 1394/12/09
Ethics committee reference number
MUBABOL.REC.1394.322

Health conditions studied

1

Description of health condition studied
attention deficit-hyperactivity disorder
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type

Primary outcomes

1

Description
ADHD-RS questionnaire
Timepoint
at the end of 4th and 8th weeks after starting treatment
Method of measurement
ADHD-RS questionnaire or attention deficit hyper activity disorder rating scale is a questionnaire which has 18 questions used for a measurement of ADHD recovery in different studies.Time for filling out the questionnaire is about 5 minutes.Psychologist asks questions from children and then completes the form of questionnaire and rates the answers.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 patients receive Ritalin (Novarits company, Riralin)
Category
Treatment - Drugs

2

Description
Intervention group: 30 patients receive Atomoxetin (Abidi company, Stramox)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yahyanejad hospital clinic
Full name of responsible person
Anjela Hamidia
Street address
Yahyanejad Hospiyal,Moddares street,Mostafa khomeinei street, Babol,Mazandaran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 0181
Email
a.hamidia@mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Anjela Hamidia
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 0181
Email
a.hamidia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Anjela Hamidia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 0181
Email
a.hamidia@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Anjela Hamidia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 0181
Email
a.hamidia@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Anjela Hamidia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 0181
Email
a.hamidia@mubabol.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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