Comparative study of the anxiolytic effect of oral ketamine and fluvoxamine in the treatment of children with separation anxiety disorder leads to school avoidance referral to subspecialty medical centers for child and adolescent psychiatry
Comparison of mean anxiety score in ketamine and fluvoxamine groups before and after treatment by controlling the variables of age, sex, family history and duration of the disorder
Design
Clinical trial with control group , With parallel groups , No blinding , randomised , Phase 3 design of 100 patients. Double random blocks were used for randomization
Settings and conduct
People referring to child and adolescent psychiatric clinics in Isfahan, which include inclusion criteria enter the study. Ketamine up to a maximum dose of 1 mg / kg and Fluvoxamine is increased to a maximum dose of 200 mg. Patients are followed for 16 weeks and Questionnaires are given to patients before treatment and in the eighth and sixteenth weeks.
Participants/Inclusion and exclusion criteria
Children between the ages of 6 and 10 are diagnosed with separation anxiety disorder and avoid school , Lack of a plan or serious suicidal thoughts , No psychiatric comorbid disorders
Intervention groups
Intervention group treated with ketamine , the other group is treated with fluvoxamine as a control group
Main outcome variables
Anxiety score, age, sex, family history, duration of the disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052670N3
Registration date:2022-06-29, 1401/04/08
Registration timing:retrospective
Last update:2022-06-29, 1401/04/08
Update count:0
Registration date
2022-06-29, 1401/04/08
Registrant information
Name
afsaneh karbasi amel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 1255
Email address
afsaneh_karbasi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the anxiolytic effect of oral ketamine and fluvoxamine in the treatment of children with separation anxiety disorder leads to school avoidance referral to subspecialty medical centers for child and adolescent psychiatry
Public title
Evaluation of the anti-anxiety effect of ketamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6 to 10 years
Diagnosis of separation anxiety disorder leads to school avoidance
Conscious consent to participate in the study
No suicidal plans or thoughts at the time of enrollment
Living in Isfahan
Exclusion criteria:
Existence of psychiatric comorbid disorders
Age
From 6 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Dual random blocks are used to assign patients to fluvoxamine and ketamine . In this way, both eligible patients are referred to the clinic by their national code and form a block .Then a table of random numbers is used. If the random number was 0-4, the first person was ketamine and the second person was fluvoxamine and if the random number is 5-9, the first person will receive fluvoxamine and the second person will receive ketamine and this process continues until the sample size is sufficient
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services , Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.MUI.MED.REC.1399.1161
Health conditions studied
1
Description of health condition studied
Separation anxiety disorder leads to school refusal
ICD-10 code
F93.0
ICD-10 code description
Separation anxiety disorder of childhood
Primary outcomes
1
Description
Anxiety score based on CATS and SCARED questionnaires
Timepoint
Before treatment and the eighth and sixteenth week
Method of measurement
Childhood Automatic Thought Scale and Screen for Child Anxiety Related Emotional Disorders questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ketamine is started at a dose of 0.1 mg / kg and on weekly visits based on patient tolerance 0.1 mg / kg is increased to a maximum dose of 1 mg / kg
Category
Treatment - Drugs
2
Description
Control group: Fluvoxamine is started at a dose of 25 mg and Depending on the tolerance of patients, it can be increased to a maximum dose of 200 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Farzaneh Hosseini
Street address
Isfahan University of Medical Sciences and Health Services , Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8007
Email
farzanehoseini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayagh hagh jooy javanmard
Street address
Isfahan University of Medical Sciences and Health Services , Hezar Jerib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8007
Email
farzanehoseini@gmail.com
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
farzaneh hosseini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Jay St.
City
Esfahan
Province
Isfehan
Postal code
8156884798
Phone
+98 31 3230 3972
Email
farzanehoseini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzane Hosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
4th floor , No. 34 , Haft Tir Alley , Rashha St. , Jay St.
City
Esfahan
Province
Isfehan
Postal code
8156884798
Phone
+98 31 3230 3972
Email
farzanehoseini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farzaneh Hoseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
4th floor , No. 34 , Haft Tir Alley , Rashha St. , Jay St.
City
Esfahan
Province
Isfehan
Postal code
8156884798
Phone
+98 31 3230 3972
Email
farzanehoseini@gmail.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be shared after people are not identified
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any kind of analysis, whether demographic or the accuracy of the results, is unrestricted
From where data/document is obtainable
farzanehoseini@gmail.com
What processes are involved for a request to access data/document