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IRCT20220118053756N1 IRCT 2022-06-12 Iran University of Medical Sciences The effect of single dose ketamine injection on reducing acute suicidal thoughts The effect of single dose injection of ketamine in comparison with midazolam on acute suicidal thoughts in psychiatric patients: a double-blind clinical trial 2022-01-21 anticipated 36 Complete https://irct.ir/trial/61365 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Ketamine and midazolam are coded as A and B. A random sequence of A and B is created using a table of random numbers which is maintained by one of the researchers. The researcher prescribing the drug is not aware of the group to which the next patient is allocated until the moment of prescribing the drug. The intervention category of each patient is specified as A or B upon administration by contacting the researcher who has access to the sequence. Midazolam and ketamine are prepared in identical appearance, are labeled as A and B, and retained for the sole purpose of this research, Blinding description: participants and evaluators and analysts are not aware of the injection of the midazolam or Ketamine . The supervisor and the attending physician are aware of the injected drug. After randomization and receiving the code, the physician will be informed through the supervisor who is aware of the received code. The evaluator and analyst will only know about group A or B.Ketamine and midazolam are both injectable and colorless and are prepared in normal saline and midazolam is injected at a low dose to reduce the sedative effect of it, which causes the study to go out of the double-blind state. 3 Condition 1: Suicide. Condition 2: Major depressive disorde. Intervention 1: Intervention group: patients with acute suicidal thoughts with ketamine injection 0.5 mg/kg. Intervention 2: Control group: patients with acute suicidal thoughts with midazolam injection0.02 mg/kg. Yes - There is a plan to make this available What will be shared: All data can be shared after encoding and being unrecognizable When: Access period from 2021 To whom: Only for researchers working in academic and scientific institutions Conditions: Any kind of analysis is allowed if it is coordinated and the source is mentioned Where to obtain: Maryam Barzkar How to obtain: Sending email to maryam.barzkar@gmail.com Comments:
public Maryam Barzkar
Iran psychiatric hospital; Next to the entrance of North Azadegan Highway; 7th km of Karaj Makhsoos road; Tehran
Tehran Iran (Islamic Republic of) ۱۳۹۸۹۱۳۱۵۱ +98 21 4450 3395 maryam.barzkar@gmail.com Iran University of Medical Sciences scientific Amir hossein Jalali Nadoushan
Iran psychiatric hospital; Next to the entrance of North Azadegan Highway; 7th km of Karaj Makhsoos road; Tehran
Tehran Iran (Islamic Republic of) ۱۳۹۸۹۱۳۱۵۱ 0098 21 ۴۴۵۰۳۳۹۵ا drjalali57@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Clients with acute suicidal ideation (thoughts that have occurred within the last 72 hours and have not existed before, with serious risk and require psychiatric hospitalization) Age range of 18-68 years old 18 years 65 years Both physical disorders such as thyroid dysfunction, diabetes, hypertension, stroke and brain surgery and other neurological disorders History of abuse or allergy to ketamine or midazolam Pregnant and lactating women Convulsion current or recent and regular antidepressant medication last month T14.91 F32.2 Suicide attempt Major depressive disorder, single episode, severe without psychotic features Treatment - Drugs Treatment - Drugs Intervention group: patients with acute suicidal thoughts with ketamine injection 0.5 mg/kg Control group: patients with acute suicidal thoughts with midazolam injection0.02 mg/kg Beck suicidal questionnaire score. Timepoint: Before injection; after 12 hours; 24 hours later. Method of measurement: Beck suicidal questionnaire. Score of visual analog scale for suicidal ideation. Timepoint: Before injection; 12 hours and 24 hours after injection. Method of measurement: Self reporting by patient. Iran University of Medical Sciences Approved 2020-04-19 National Research Ethics Committee Tehran Hemat Highway next to Milad Tower، 14535 tehran Tehran Iran (Islamic Republic of)