Study the effects of combination treatment of Tizanidine with long acting Stimulants in Attention Deficit Hyperactivity Disorder
Design
randomized clinical trial, parallel group, double blinded, randomized,phase3 on 40 ADHD patients between age 9-18 years, Randomization carried out with an external site(randomizer.org)
Settings and conduct
This trial will be conducted during 3 phases(0,1,2 month) in resistant ADHD patients between age 9-18 that be visited in outpatient units or admission wards of department of child psychiatry of Isfahan University of Medical Sciences. all of participants, health care providers(that are involved in offering drug or placebo) and data collectors and assessors will be blinded with similarity in form and shape of drug and placebo and numerical codes for each participants instead of name in all time of study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Clinical diagnosis of ADHD according to Diagnostic and Statistical Manual of mental disorder-5 (DSM-5) criteria, completing the informed consent form by patient and parents, negative history of receiving any Antihypertensive drug or Alfa blocker or Beta blockers, negative history of allergic reaction to drug. exclusion criteria: unwillingness of patient or family to continue the study and any new medical or mental conditions that effects treatment procedure.
Intervention groups
Intervention group will receive combination of Vyase and Tizanidine (drug A)and control group will receive Vyase and placebo(drug B)
Main outcome variables
In the beginning of study and in end of month 1 and 2, severity of ADHD will be assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230619058530N2
Registration date:2023-10-14, 1402/07/22
Registration timing:prospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Mostafa Haghshenas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8000
Email address
m.hagshenas@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-04-17, 1403/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized Clinical Trial, effects of combination treatment with Tizanidine and long-acting Stimulants in ADHD.
Public title
Effects of combination treatment with Tizanidine and long-acting Stimulants in ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-5 criteria
completing the informed consent form by parent and patient
negative history for any chronic medical diseases
negative history for drug induced allergy
negative history of receiving any Anti hypertensive, Alpha blockers or Beta blockers during recent three months before study
Lack of history of any comorbid psychiatric disorder
Exclusion criteria:
Any unexpected physical or mental condition that effects on treatment regimen
unwillingness of patients or parents to continue study procedure
Age
From 9 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
according to time sequence of visits, each sample will give specific code between 1-40 and then, by means of an online computer randomization tool(random.org),they will be randomized in intervention or placebo group with a simple randomization manner by a 1:1 ratio. For blinding, each participant would be shown as an numerical code until the end of study.
Blinding (investigator's opinion)
Double blinded
Blinding description
blinding procedure in both intervention and control groups will be done by similarity in shape of drug and placebo. blinding of principle investigator will be done by random placing of participants in both control and intervention groups and each participant will have a numerical code. health care providers offer the drug and placebo base on A and B codes to participants. with a similar process, that mentioned above, data collectors and outcome assessors will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the "Alzahra Research Centers
Street address
Hezar-Jerib street
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-08-22, 1402/05/31
Ethics committee reference number
IR.ARI.MUI.REC.1402.135
Health conditions studied
1
Description of health condition studied
Attention-deficit hyperactivity disorders
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
ADHD severity
Timepoint
Before intervention and 1,2 months after intervention
Method of measurement
conners questioner
Secondary outcomes
1
Description
blood pressure
Timepoint
Before intervention and 1,2 months after intervention
Method of measurement
Standard mercury sphygmomanometer
Intervention groups
1
Description
Intervention group: tizanidine tablet (Tizanidine 4MG TAB, Hakim Pharmacy) with dose 1-4mg daily, divided doses orally for 2 month
Category
Treatment - Drugs
2
Description
Control group: placebo tablet(School of Pharmacy and Pharmaceutical SciencesSchool of Isfahan University of Medical Sciences) contains starch and calcium diphosphate ,orally and divided daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Majid Hosseinzadeh
Street address
Ebn e Sina street
City
esfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 1445 5051
Email
Amin@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezar Jerib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mostafa Haghshenas
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hezar Jerib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Email
haghshenas2005@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mostafa Haghshenas
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hezar-Jerib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Email
haghshenas2005@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mostafa Haghshenas
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hezar-Jerib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2475
Email
haghshenas2005@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