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IRCT20190317043079N4 IRCT 2023-04-25 Babol University of Medical Sciences The effectiveness of ketamine on suicidal ideation Comparing the effectiveness of ketamine and placebo on suicidal ideation 2023-04-25 anticipated 90 Complete https://irct.ir/trial/69598 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using permutation blocks of size 4 (AABB). Patients will be randomly assigned to two groups of 45 using 25 blocks of size 4 and 1:1 ratio. Creating a random sequence in the blocks will be done by a statistician through the block randomization site, Blinding description: The solutions required for infusion (ketamine 0.5mg/kg and ketamine 0.75mg/kg and placebo containing 0.9% saline) are prepared by the pharmacology expert consultant of the project in similar shape, size and color and are available to the specialist assistant of psychiatry who is the project manager. will be placed The solutions are coded separately and only the pharmacology specialist will know about the codes. 3 Major Depressive Disorder. Intervention 1: Intervention group: Ketamine with a dose of 0.75-0.50 mg/kg as a 40-minute infusion. Intervention 2: Control group: 0.9% saline as a 40-minute infusion. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Farzan Kheirkhah
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4713566547 +98 11 3233 8301 f.kheirkhah@mubabol.ac.ir Babol University of Medical Sciences scientific Farzan Kheirkhah
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 4713566547 +98 11 3233 8301 f.kheirkhah@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) having a major depressive episode based on a clinical interview (based on DSM-5) A total score of more than 5 on the Beck suicidal ideation scale A score of 14 or higher in the Beck depression questionnaire Absence of pregnancy or lactation Absence of obvious cognitive impairment or mental retardation 18 years no limit Both Receiving psychiatric medications within a month before starting ketamine treatment History of sensitivity to ketamine F06.32 Mood disorder due to known physiological condition with major depressive-like episode Treatment - Drugs Treatment - Drugs Intervention group: Ketamine with a dose of 0.75-0.50 mg/kg as a 40-minute infusion Control group: 0.9% saline as a 40-minute infusion Suicidal Ideation. Timepoint: 48 hours after receiving the infusion. Method of measurement: Beck scale suicide ideation questionaire. Babol University of Medical Sciences Approved 2023-03-12 Ethics Committee of Health research institu-Babol University of Medical Siences Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)