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IRCT20160105025859N1 IRCT 2019-06-08 Shiraz University of Medical Sciences evaluation of s-ketamine effects on reducing suicidal thoughts and behaviors in major depressive disorder The Permanent Effects of double doses of intravenous Es-Ketamine on suicidal thoughts and behaviors in the Major depressive disorder: a randomized double-blind placebo-controlled clinical trial study 2019-05-20 anticipated 90 Complete https://irct.ir/trial/38531 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients included in the study were all under treatment with SSRIs(selective serotonin reuptake inhibitors) class and if another medication modalities that have confirmed antidepressant effect (such as lithium or ECT) were considered by physician to treat suicidal ideation, they excluded from the study, Randomization description: Patients who meet our inclusion criteria will be randomly allocated into 2 groups using a permuted block randomization method (using blocks of two), Blinding description: The evaluating researcher and the patients will be unaware of the treatment protocol. All treatment modalities will be carried out by an independent medical professional. All patients will be followed by a single observer who will solely be responsible for the evaluation of outcomes. This investigator will be unaware of patient treatment and grouping. Patients will be referred to the investigator for evaluation after receiving planned intervention and any information on the intervention program prior to the visit will be controlled by a clinical trial nurse who will be responsible for control of data related to the intervention program. 3 Suicidal thoughts and behaviors. Intervention 1: Intervention group: Those diagnosed with major depressive disorders who aside to their routine and standard treatment will receive a dose of 0.5mg/Kg of Es-Ketamine Hydrochloride from KETAMIN ROTEXMEDICA injection 50mg/ml, 10 ml, diluted in 100 cc normal saline, during 45 minutes in day 1 and 14. Intervention 2: Control group: Those diagnosed with major depressive disorder who will receive a dose of 0.5mg/Kg of intravenous Es-ketamin in day 1 and a dose of 0.045mg/Kg intravenous MIDAZOLAM ABURIHAN ampul 5mg/ml,1ml, in day 14. all medications will dilute in 100cc normal saline and infuse during 45 minutes. Yes - There is a plan to make this available What will be shared: results of the main consequences will share. When: 6 months after printing results To whom: share with Scientific institutions Conditions: for any other researches Where to obtain: Contact with samane7rahimi86@yahoo.com How to obtain: Data will share within 3 months after contact via E-mail Comments:
public Laya Ahmadzade
Chamran Blvd.,Hafez hospital
Shiraz Iran (Islamic Republic of) 7194634786 +98 71 3647 9531 ahmadzadel@sums.ac.ir Shiraz University of Medical Sciences scientific Laya Ahmadzade
Chamran Blvd.,Hafez hospital
Shiraz Iran (Islamic Republic of) 7194634786 +98 71 3647 9531 ahmadzadel@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) This clinical trial study will be conducted in Ebne Sina and Hafez Hospital, Shiraz, Iran and all patients who are admitted to our medical care center during a one year period with complaints of suicidal ideas and with a diagnosis of DSM-5 major depressive disorder (MDD), 18 years 65 years Both Those who have a positive history of alcohol or substance abuse during the past 6 months mood disorders due to any medical conditions pregnancy or lactation those with a positive history of ketamine abuse those with symptoms of psychosis unstable medical conditions with hypersensitivity to ketamine positive history of use of psychotropic agents or drugs like corticosteroids Treatment - Drugs Placebo Intervention group: Those diagnosed with major depressive disorders who aside to their routine and standard treatment will receive a dose of 0.5mg/Kg of Es-Ketamine Hydrochloride from KETAMIN ROTEXMEDICA injection 50mg/ml, 10 ml, diluted in 100 cc normal saline, during 45 minutes in day 1 and 14. Control group: Those diagnosed with major depressive disorder who will receive a dose of 0.5mg/Kg of intravenous Es-ketamin in day 1 and a dose of 0.045mg/Kg intravenous MIDAZOLAM ABURIHAN ampul 5mg/ml,1ml, in day 14. all medications will dilute in 100cc normal saline and infuse during 45 minutes. Suicidal thoughts and behaviors. Timepoint: Patients will be evaluated at baseline (8 hours before infusion), 24 hours, 7 and 10 days and two weeks after each infusions of Es-Ketamine or Midazolam in both groups. Method of measurement: The Beck Scale for Suicide Ideation (BSSI). Es-Ketamine administration will reduce symptoms of patients with Major Depressive disorder 2weeks post infusion. Timepoint: before and 2 weeks after Es-Ketamine or Midazolam infusion. Method of measurement: Hamilton Rating Scale for Depression (HRSD). Shiraz University of Medical Sciences Approved 2019-02-19 Ethics committee of Shiraz university of medical sciences Zand Avn. Shiraz Fars Iran (Islamic Republic of)