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IRCT20211004052670N3 IRCT 2022-06-29 Esfahan University of Medical Sciences Evaluation of the anti-anxiety effect of ketamine 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 2021-11-22 anticipated 100 Complete https://irct.ir/trial/59247 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 Separation anxiety disorder leads to school refusal. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data can be shared after people are not identified When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Any kind of analysis, whether demographic or the accuracy of the results, is unrestricted Where to obtain: farzanehoseini@gmail.com How to obtain: Checked as soon as possible Comments:
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Esfahan Iran (Islamic Republic of) 8156884798 +98 31 3230 3972 farzanehoseini@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 6 years 10 years Both Existence of psychiatric comorbid disorders F93.0 Separation anxiety disorder of childhood Treatment - Drugs Treatment - Drugs 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 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 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. Esfahan University of Medical Sciences Approved 2021-03-14 Ethics committee of Esfahan University of Medical Sciences Isfahan University of Medical Sciences and Health Services , Hezar Jerib St. Esfahan Isfehan Iran (Islamic Republic of)