Protocol summary

Study aim
Determining the effectiveness of Ritalin, Stimedit and Practicesa drugs in primary school children with attention deficit hyperactivity disorder
Design
Clinical trial, Double-blind, Randomized phase 2 on 60 patients, Block allocation method will be used for randomization.
Settings and conduct
The study will be conducted on children suffering from attention-deficit hyperactivity disorder referred to the Ba'ath Hospital clinic in Sanandaj.
Participants/Inclusion and exclusion criteria
Entry Criteria: 1. The age of these children should be 6 to 12 years. 2. Based on the diagnostic criteria of DSM-5, a child and adolescent psychiatry specialist should diagnose attention deficit hyperactivity disorder in children. Study exclusion criteria: 1. Existence of serious physical disease such as seizure disease, heart disease based on parents' history and clinical suspicion 2. Presence of accompanying psychiatric disorder 3. Mental retardation based on clinical suspicion 4. Taking drugs for attention deficit hyperactivity disorder in the last month
Intervention groups
Intervention group: The patients included in the study are divided into three groups during a period of 8 weeks. Each group is given one of the drugs Ritalin, Methylphenidate Iranian Stimulant or Practice. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed.
Main outcome variables
The person's score is based on Parent's ADHD Rating scale and CGI (Clinical Global Impressions) questionnaires.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160530028182N10
Registration date: 2023-09-20, 1402/06/29
Registration timing: registered_while_recruiting

Last update: 2023-09-20, 1402/06/29
Update count: 0
Registration date
2023-09-20, 1402/06/29
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
2023-06-22, 1402/04/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Ritalin, Stimdate and Practisa in primary school children with Attention Deficit Hyperactivity Disorder
Public title
Effectiveness of Ritalin, Stimedit and Practisa in primary school children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of these children is 6 to 12. Based on the diagnostic criteria of DSM-5, the child and adolescent psychiatry specialist should diagnose attention deficit hyperactivity disorder in children.
Exclusion criteria:
Existence of serious physical disease such as seizure disease, heart disease based on parents' history and clinical suspicion Presence of accompanying psychiatric disorder Mental retardation based on clinical suspicion Taking drugs for attention deficit hyperactivity disorder in the last month
Age
From 6 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block allocation method will be used for random allocation in this study. In this way, according to age, patients are categorized into two age groups: 6-8 years old and 9-11 years old. Then the patients have criteria for entering the study based on whether they are in the group of 6-8 years old or the group of 9-11 years old and based on coincidence, the first person aged 6-8 years old is in one of the treatment groups and the second and third person aged 6-8 years old respectively in The second and third groups of treatment are placed, and also based on the coincidence, the first person aged 9-11 is placed in one of the treatment groups, and the second and third person, 9-11 years old, are placed in the second and third treatment groups, respectively, and this process continues until completion. The sample size will continue. How to group, allocate and blind: In order for the study to be double-blind, the researcher randomly divides the subjects into groups 1, 2, and 3, and they are referred to the person responsible for the treatment (pharmacy) with such a code. Ritalin, Stimedit and Practisa are placed in the same capsules and are given to patients by the pharmacy in pre-prepared envelopes according to codes 1, 2 and 3. The therapeutic dose of methylphenidate tablets 10 mg manufactured by Novartis company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week (daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily , one in the morning and one in the evening) is recommended. It should be noted that it will be done in the same way in each age group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient does not know in which treatment group he has been placed, the patient's family also does not know in which treatment group he has been studied due to the fact that their patient receives standard treatment, and also the measurement subjects. The clinical outcome provider does not know how to categorize and how to group the studied subjects. Medicines are prepared and provided in coded packages that only the pharmacist is in the process of coding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
No. 1, Pasdaran Blvd. Sanandaj Town
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2022-11-08, 1401/08/17
Ethics committee reference number
IR.MUK.REC.1401.295

Health conditions studied

1

Description of health condition studied
Attention-Deficit Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type

Primary outcomes

1

Description
Clinical Global Impressions Number
Timepoint
The beginning of the study (basic), 2 weeks, 4 weeks and 8 weeks after the study
Method of measurement
Clinical Global Impressions

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups. The first group is Iranian methylphenidate (stimulant) 10 mg manufactured by Mehr Daru company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week ( daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed.
Category
Treatment - Drugs

2

Description
Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups. The second group is Iranian methylphenidate (Practisa) 10 mg manufactured by Vana Daru Gostar company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week ( daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed.
Category
Treatment - Drugs

3

Description
Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups. The third group is Ritalin 10 mg manufactured by Novartis for the first week (daily, a quarter in the morning and a quarter in the evening), the second week (daily, a quarter in the morning and a quarter in the evening). one second in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. It will be given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital Sanandaj
Full name of responsible person
Soliman Mohammadzadeh
Street address
No. 1, Keshavarz St., South Mardukh St., Sanandaj Town
City
Sanandaj
Province
Kurdistan
Postal code
6617113141
Phone
+98 87 3328 5910
Fax
+98 87 3328 5911
Email
dr.mohammadzadeh86@muk.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Malaki
Street address
No. 1, Pasdaran Blv. Sanandaj Town
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Soliman Mohammadzadeh
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soliman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
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
Soliman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1. Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data of participants
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Researchers in this field
From where data/document is obtainable
dr.mohammadzadeh86@muk.ac.ir
What processes are involved for a request to access data/document
2 Month
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