The aim of this study was to evaluate the effect of betahistine on hyperactivity disorder in children.
Design
In this study, 76 patients with ADHD in the age range of 8-18 years old who are diagnosed with a child and adolescent psychiatrist are eligible to enter the study. Participants were randomly assigned to two intervention and control groups, and each participant was assigned a code. For 38 patients, one group received methylphenidate and betatisin tablets, and 38 patients received the second group of methylphenidate tablets and placebo.
Settings and conduct
The study included 76 patients with hyperactivity disorder who referred to the clinic of Besat Hospital in Sanandaj. The participants were randomly divided into two intervention groups. The first group received methylphenidate and betahistin and the methylphenidate and polassabs control group.
Participants/Inclusion and exclusion criteria
Having diagnostic criteria based on DSM-5 for ADHD with ODD; age 8 to 18 years; failure to use any effective psychological condition at least 2 weeks before the study. Exit conditions: Intellectual disability according to clinical suspicion; controlled seizure; complications and drug allergy.
Intervention groups
The research consisted of 76 participants who were randomly assigned to receive intervention and control group. Ritalin 10 mg for the first week of the week (one half a tablet at 8:00 and half a tablet at 14), from the second weekly 2 tablets (one morning) At 8 o'clock, one hour at 14 o'clock. The dose is 8 mg for the first week of the week, one tablet (half a tablet at 8 o'clock and half a tablet at 14 o'clock), and from the second week, 2 tablets (one morning at 8 o'clock, one o'clock 14 o'clock).
Main outcome variables
Treatment for ADHD patients
side effects comparison
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160530028182N6
Registration date:2019-05-15, 1398/02/25
Registration timing:retrospective
Last update:2019-05-15, 1398/02/25
Update count:0
Registration date
2019-05-15, 1398/02/25
Registrant information
Name
Soleiman Mohammadzadeh
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 2168
Email address
dr.mohammadzadeh86@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of betahistine on hyperactivity disorder in children
Public title
Aripiprazle in ADHD and ODD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 8-18 years
Diagnosis of ADHD and ODD based on DSM5 without effective medication
Taking on mental status at least 2 weeks before the study
Exclusion criteria:
Intelectual disability based on clinical suspicious
Presence of uncontroled siezure
Drug side effects and hypersensivity
Recieving of any other drugs
History of psychological disorder except for ADHD and ODD
Presence of medical diseases such as cardiac diseases
Age
From 8 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Individual based-simple randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug is prepared by the pharmacist and in coding packages which only the pharmacist is aware of its coding and deliverd by researcher to the patient. Neither the investigator, nor the patient nor the analyst, knows the contents of the drug packages and the way they are coded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdestan University of Medical Sciences
Street address
Pasdaran street Sanandaj
City
ُSanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2016-08-13, 1395/05/23
Ethics committee reference number
IR.MUK.REC.1395.135
Health conditions studied
1
Description of health condition studied
Attention deficit/hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention deficit/hyperactivity disorder
Primary outcomes
1
Description
Improvment in Attention-deficit symptoms
Timepoint
Baselin, second, fourth and eighth weeks after intervention
Method of measurement
Canner's and ADHD Rating scales
Secondary outcomes
1
Description
Severity of ADHD symptoms
Timepoint
Baselin, second, fourth and eighth weeks after intervention
Method of measurement
ADHD Rating scale and CGI
Intervention groups
1
Description
Intervention group: the research consisted of 76 participants who were randomly assigned to receive intervention and control group. Ritalin 10 mg for the first week of the week (one half a tablet at 8:00 and half a tablet at 14), from the second weekly 2 tablets (one morning) At 8 o'clock, one o'clock 14) and in the case of a weight of over 30 kilograms, from the second week, 3 tablets (one and a half hours at 8 o'clock, one and half hours at 14 o'clock) are prescribed daily. The dosage is 8 mg per day for the first week of the week (half a tablet at 8:00 and half a tablet at 14) and from the second week, 2 tablets (one morning at 8, one hour at 14)
Category
Treatment - Drugs
2
Description
Control group: Ritalin 10 mg for the first week of the week (one half a tablet at 8:00 and half a tablet at 14), from the second weekly 2 tablets (one morning) At 8 o'clock, one o'clock 14) and in the case of a weight of over 30 kilograms, from the second week, 3 tablets (one and a half hours at 8 o'clock, one and half hours at 14 o'clock) are prescribed daily. herapeutic dosage of placebo is prescribed a tablet daily for the first week ( one cap in the morning at 8 o'clock) and 2 cap are daily prescribed in the second week (one cap in the morning at 8 o'clock, one cap at 16 o'clock).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical, Educational and Terapeutic Center of Besat Hospital
Full name of responsible person
Soleiman Mohammadzadeh
Street address
Medical, Educational and Terapeutic Center of Besat Hospital, Keshawarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6619667761
Phone
+98 87 3328 2004
Email
dr.mohammadzadeh86@muk.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Farzin Rezaie
Street address
pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
frrezaie@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Soleiman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran street Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
dr.mohammadzadeh86@muk.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Soleiman Mohammadzadeh
Position
ََAssociate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran street
City
sanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
dr.mohammadzadeh86@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr.Soleiman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
dr.mohammadzadeh86@muk.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available