1. Comparison of the mean score of child behavior in the intervention group with the mean score of the control group before, 2, 6 and 12 weeks after the intervention
2. Comparison of symptoms score mean of Oppositional defiant Disorder (ODD) in the intervention group with the mean score of the control group before, 2, 6 and 12 weeks after the intervention
3. Comparison of changes in the mean score of child behavior between the intervention and control groups before, 2, 6 and 12 weeks after the intervention
4. Comparison of changes in the mean score of symptoms of Oppositional defiant Disorder (ODD) in the intervention and control groups before, 2, 6 and 12 weeks after the intervention
Design
Two-group clinical trial with placebo group with double-blind randomization, 80 patients based on inclusion criteria
Settings and conduct
The doctor and the patient will not have information about the study (two blinds). Sarcosine and placebo powder is prepared by the Faculty of Pharmacy of Isfahan University of Medical Sciences in the form of 0.3 g capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Boys and girls aged 6 to 12 years and diagnosis of Oppositional defiant Disorder (ODD) based on the DSM-V.
2. Parents' consent to participate in the study
Exclusion criteria:
1- Disinclination of patients to participate in any stage of the study
2- No consumption of the drug accurately by patient
3- Patients for whom another diagnosis is made during the study.
Intervention groups
Sarcosine and placebo powder is prepared by Isfahan University of Medical Sciences in the form of 0.3 g capsules and will be prescribed to patients with the same appearance, color and smell at a dose of 0.03 g per kg daily.
Main outcome variables
Improve treatment
General information
Reason for update
Acronym
PMT
IRCT registration information
IRCT registration number:IRCT20211022052836N1
Registration date:2022-06-13, 1401/03/23
Registration timing:retrospective
Last update:2022-06-13, 1401/03/23
Update count:0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Saeed Alvandian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
ghadamifa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
2019-12-22, 1398/10/01
Actual recruitment end date
2021-12-22, 1400/10/01
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of adding sarcosine to PMT (parental education management) treatment on the symptoms of coping disorder
Public title
Evaluation of the effectiveness of sarcosine to parental education management treatment on the symptoms of coping disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Girl and boy children aged 6 to 12 years who have been diagnosed with coping disorder by a psychiatrist based on the DSM-V. 2. Parents' consent to participate in the study
Exclusion criteria:
1- Patients who do not want to continue participating in the study at any stage. 2- Patients who do not plan their medication according to the prescribed medication and do not take it accurately. 3- Patients for whom another diagnosis is made during the study.
Age
From 6 years old to 12 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
80
More than 1 sample in each individual
Actual sample size in each individual:
80
Due to the lack of a similar study, the required number of samples as a pilot in each group is considered 40 people.
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the lack of a similar study, the required number of samples as a pilot in each group of 40 people are considered. These samples are easily selected from patients who refer to a pediatric psychiatric clinic.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and principal researcher
Physician and patient will not have information about the study (two blinds)
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
814673461
Approval date
2022-07-23, 1401/05/01
Ethics committee reference number
IR.MUI.MED.REC.1400.162
Health conditions studied
1
Description of health condition studied
Oppositional Defiant Disorder
ICD-10 code
F91/3
ICD-10 code description
F91/3
Primary outcomes
1
Description
Percentage of people with Oppositional Defiant Disorder
Timepoint
At the beginning of the study, 2, 6 and 12 weeks after treatment
Method of measurement
Inventory Oppositional defiant behavioral Questionnaire (ODBI) and Demographic Information Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sarcosine powder in the form of 0.3 g capsules with a dose of 0.03 g per kg daily for the patient
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Pharmacy and Pharmaceutical of Isfahan University of Medical Sciences Sciences
Full name of responsible person
Mojgan karahmadi
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
karahmad@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan karahmadi
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
karahmad@med.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
Mojgan karahmadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان اصفهان
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
karahmad@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan karahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
karahmad@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan karahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
اصفهان، خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان اصفهان
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
karahmad@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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