Comparison of the effect of Attentalin and Atomoxetine in the treatment of patients with ADHD
Design
randomized clilinical trial ,double blind, third phase on 46 patients
Settings and conduct
This research is about to be conducted in the field of treatment of psychiatric disorders of children and adolescents .
The place where it is performed is the specialized psychiatry clinic of Sina Psychiatric Hospital in Hamedan.
After the initial assessment, children aged 6 to 12 with ADHD according to DSM5 criteria were divided into two groups , and medication was prescribed and they will be followed up three times at 0, after 3 weeks and after 6 weeks by ADHD-rating-scale questionnaire One group will receive Attentalin syrup and placebo capsules, and the other group will receive placebo syrup and Atomoxetine capsules.lt is a double blind study, researchers and patient are blindedby one of staff of clinicThe patients are not aware of the type of medicine used and each group does not know about the other group.
Participants/Inclusion and exclusion criteria
1.Pediatric patient with attention deficit hyperactivity disorder from age 6 to 12 both genders based on dsm 5 criteria
2. Obtaining the informed consent from parents
Exclusion criteria:
1. Children with history of Hyperthyroidism, seizure, eating disorders (anorexia) , glaucoma,
2.substance use disorders
3.Children who used MAOI drugs during recent 15 days.
4.Children with hepatic, cardiac, renal or chronic diseases which have required special care
Intervention groups
we have put patientes in two group . one group takes Attentalin syrup and placebo capsuleanother group takes placebo syrup and Atomoxetin capsule.
Main outcome variables
attention deficit and hyperactivity symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230419057960N1
Registration date:2023-10-08, 1402/07/16
Registration timing:prospective
Last update:2023-10-08, 1402/07/16
Update count:0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
Atiyeh Majidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 1094
Email address
a.majidi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Attentalin and Atomoxetin in treatment of the attention deficit and hyper activity disorder
Public title
Comparison the efficacy of Attentalin and Atomoxetin in ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who recieved Attentin Deficite and Hyoeractivity Disorder due to DSM 5 criteria .
Obtaining Informed consent from parents
Age 6 to 12 years old
Exclusion criteria:
Seizures
Glaucoma
History of hyperthyroidism
Eating disorders (anorexia)
Children with a history of liver , kidney , heart diseases or other chronic illnesses requiring care
Children who have taken MAOI medication for the 15 days prior to entering the study.
substance abuse disorder
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization : we use simple randomization and devided patient to two group A and B
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are divided into two groups, A and B. In one group, Attentalin syrup and placebo capsules are given, and in the other group, placebo syrup and Atomoxetine capsules are given.The patients has no knowledge about the other group, the drugs used and the placebo in the research are given to the patients by one of the clinic personnel with a specific code , so the researchers and the patient do not know the type of drug used.
The data obtained from the study of the patients are collected by the researcher and are provided to the analyst and statistician in a private manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Science
Street address
Kasshani
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.UMSHA.REC.1401.1083
Health conditions studied
1
Description of health condition studied
Attention deficit and hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Symptoms of hyperactivity/attention deficit
Timepoint
before the trial and 3 and 6 weeks later
Method of measurement
ADHD Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: The patient's weight, blood pressure and pulse are measured, physical symptoms and complaints are asked from the patient and parents. In this group, patients are treated with atomoxetine capsules with a starting dose of 0.5 mg per kilogram of weight, then after a week, the dose reaches 1 mg per kilogram of weight and the treatment continues. ADHD RATING SCALE questionnaire will be completed by the psychiatric resident on day zero and in week 3 and 6.
Category
Treatment - Drugs
2
Description
Intervention group B : The patient's weight, blood pressure and pulse are measured, physical symptoms and complaints are asked from the patient and parents. In this group, 23 patients are treated with Attentalin syrup with a starting dose of 5 cc/day then 10 cc/day after a week, . ADHD RATING SCALE questionnaire will be completed by the psychiatric resident on day zero and in week 3 and 6.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Atiyeh Majidi
Street address
Honarestan
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 0410
Email
meytalaat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Atiyeh Majidi
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Honarestan
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 9345
Email
meytalaat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Helen Behmanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Honarestan
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 9344
Email
Behmanesh.helen@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
atiyeh Majidi
Position
psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Honarestan
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
009881738274184
Email
meytalaat@gmail.com
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