Ropinirole as an adjuvant therapy with methylphenidate in the treatment of ADHD in children: A randomized, double-blind, placebo-controlled clinical trial
Evaluating the efficacy of Ropinirole for the treatment of ADHD
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
This study will be performed on patients attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: ADHD diagnosis based on DSM5 - Children between 6-17 years old. Exclusion criteria: Presence of severe medical illness, neurological problems and problems requiring surgery - Presence of any concomitant psychiatric disorder that requires treatment with psychiatric drugs except ODD - History of treatment with ropinirole in the three months prior to the study - Consumption neuroleptic medication in the last 6 months - Weight less than 13.5 kg - Mental retardation - Uncontrolled seizure disorder - Systolic blood pressure above 125 mm Hg or Resting pulse rate less than 60 beats per minute or above 115 beats per minute - Using any medicine or supplement for the treatment of ADHD - History of allergy to methylphenidate or ropinirole
Intervention groups
Control group: Ritalin, 0.1-3.5 mg per kg of body weight, for the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. Placebo is prescribed twice a day. Total duration of treatment is 8 weeks.
Intervention group: Ritalin (like control group). Ropinirole is prescribed at a dose of 0.25 mg twice a day. Total duration of treatment is 8 weeks.
Main outcome variables
Severity of ADHD symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N151
Registration date:2023-06-19, 1402/03/29
Registration timing:prospective
Last update:2023-06-19, 1402/03/29
Update count:0
Registration date
2023-06-19, 1402/03/29
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ropinirole as an adjuvant therapy with methylphenidate in the treatment of ADHD in children: A randomized, double-blind, placebo-controlled clinical trial
Public title
The efficacy of Ropinirole in the improvement of ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ADHD diagnosis based on DSM5
Children between 6-17 years old.
Exclusion criteria:
Presence of severe medical illness, neurological problems and problems requiring surgery
Presence of any concomitant psychiatric disorder that requires treatment with psychiatric drugs except ODD
History of treatment with ropinirole in the three months prior to the study
Consumption neuroleptic medication in the last 6 months
Weight less than 13.5 kg
Mental retardation
Uncontrolled seizure disorder
Systolic blood pressure above 125 mm Hg or Resting pulse rate less than 60 beats per minute or above 115 beats per minute
Using any medicine or supplement for the treatment of ADHD
History of allergy to methylphenidate or ropinirole
Age
From 6 years old to 17 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups).
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.151
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Severity of ADHD
Timepoint
Weeks: 0 , 4 , 8
Method of measurement
By ADHD Rating Scale (by parents or teacher)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Ritalin, 0.1-3.5 mg per kg of body weight. For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. Placebo is prescribed twice a day. Total duration of treatment is 8 weeks.
Category
Placebo
2
Description
Intervention group: Ritalin, 0.1-3.5 mg per kg of body weight. For the first week, one tablet daily (1.2 tablets at the morning, 1.2 tablets at the noon), and for the second week, one tablet at the morning and one tablet at the noon. If the patient's weight is over 30 kg, three pills are prescribed daily, 1 at the morning, 1 at the noon, and 1 at the afternoon (4 p.m.), from the third week. Ropinirole is prescribed at a dose of 0.25 mg twice a day. Total duration of treatment is 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5541 2222
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.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
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2023 to 2028
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Users should cite the resource of data
From where data/document is obtainable
Prof. Shahin Akhondzadeh
What processes are involved for a request to access data/document