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IRCT20141209020258N182 IRCT 2023-05-07 Arak University of Medical Sciences The effect of single dose of ketamine injection in reducing suicidal ideation in type 1 bipolardisorder patients in the depressive phase The effect of single dose of ketamine injection in reducing suicidal ideation in type 1 bipolardisorder patients in the depressive phase 2023-05-20 anticipated 124 Complete https://irct.ir/trial/69878 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: This study will be double-blind, considering that both groups receive the drug in the form of serum and the form of injection in both groups is the same, the patients will not know what treatment they are receiving. Also, on this basis, in order to divide the patients, an envelope was used, which was determined based on the letters A (intervention group) and B (placebo group), and based on this, the patient and the doctor were blinded to the patient group. After obtaining the consent of the guardian, the patient enters the study and the medicine is prepared by the anesthesiologist and given to the anesthesiologist and the injection is done under the supervision of the anesthesiologist and psychiatry resident. Based on this, the patients and the psychiatric assistant and the anesthesia technician are blind to the type of drug and the group of patients, but the anesthesiologist who prepares the drugs and provides them to the assistant and the technician for injection is unaware of the type of drugs. 2-3 type 1 bipolardisorder patients in the depressive phase. Intervention 1: Intervention group: They will receive intravenous ketamine (0.5 mg for every kilogram of intravenous ketamine over 30 minutes). Intervention 2: Control group: normal saline (500 millileter of normal intravenous saline) will be used as a placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 68 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr Hamidreza Jamilian
Amirkabir hospital, Parastar square
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 Jamilian@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Patients with bipolar disorder type 1 in the depressive phase according to DSM5 criteria and having suicidal thoughts No drug use in the last month. Not receiving electric shock during the last month and during recent hospitalization. 15 to 65 years No mental retardation Absence of underlying disease No history of stroke, seizure, brain tumor, dementia and being in delirium phase No history of head injury and loss of consciousness Not using all kinds of drugs and alcohol in the past month 15 years 65 years Both Lack of consent of the patient or guardian to participate in the study Drug sensitivity F06.31 Mood disorder due to known physiological condition with depressive features Treatment - Drugs Treatment - Drugs Intervention group: They will receive intravenous ketamine (0.5 mg for every kilogram of intravenous ketamine over 30 minutes). Control group: normal saline (500 millileter of normal intravenous saline) will be used as a placebo. Suicidal ideation. Timepoint: Start of the study, 2, 24 and 72 hours after the start of the study. Method of measurement: Beck Suicidal Ideation Scale. Arak University of Medical Sciences Approved Approved 2023-01-09 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)