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IRCT20211214053411N1 IRCT 2022-02-10 Shiraz University of Medical Sciences Comparison of the effectiveness of ketamine with buprenorphine in depression associated with opium use Comparison of the efficacy and safety of adjunctive therapy using Ketamine with Bupronorphine for patients with major depressive disorder and contaminant opium abuse: A randomized double blind, placebo- controlled clinical trial 2022-02-20 anticipated 60 Complete https://irct.ir/trial/60716 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random list is created by a statistician using the Number Cruncher statistical system (NCSS statistical software system) using the simple block random method. Then, the eligible patients will be divided into two categories according to a random list by our fellow researcher in charge of the ECT unit of Ebne Sina Hospital (where ketamine treatment is performed by anesthesiologist). All participants and researchers are blind to patient allocation, Blinding description: Participants, the main researcher, and those who evaluate the outcome to analyze the data and those who prepare the draft article, are kept blinded by blind studies. Only those who have not blinded in this study are nurses responsible for injection of intravenous drugs, which are not involved in the process of evaluating patients before and after intervention. Considering that in both groups, the patients will receive injectable and oral drugs, for blinding the researcher and patient , two types of similar packages with opaque coating will be prepared, which first type contains of normal saline bottle, distilled water vial and bopronurfin pills and the other type package contains normal saline bottle, ketamine vial and placebo pills. Packages are numbered based on the random list. After completing the study, the list of packages will be decoded by the researcher. The nurses that inject the drug will also be reminded that they will not provide information on the content of the packages to researcher or patients. The shape of vials and serum and tablets will be very similar. N/A Condition 1: Depression. Condition 2: Suicide idea. Condition 3: Opioids abuse. Intervention 1: Intervention-control group A: Patients in this group receive infusion ketamine as an intervention and oral placebo tablet as control. . Ketamine hydrochloride will receive at a dose of 0.5mg/kg, diluted in 0.9% saline, over a 40-minute period by intravenous pump. In addition, two placebo pills will take sublingually. Intervention 2: Intervention-control group B: Patients will receive oral buprenorphine as intervention and saline infusion as placebo.In this group, patients take two buprenorphine 8 mg tablets sublingually. In addition, they will receive 0.9% normal saline serum for 40 minutes by intravenous pump. 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. Amir Bazrafshan
Psychiatry department, Hafez hospital, Chamran Blvd., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7194634786 009871336479531 bazrafshan_amir@yahoo.com Shiraz University of Medical Sciences scientific Dr. Amir Bazrafshan
Psychiatry department, Hafez hospital, Chamran Blvd., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7194634786 +98 71 3647 9531 bazrafshan_amir@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients admitted to Ebn Sina Hospital in Shiraz with a diagnosis of major depression or depression induced by opioid use Age between 18 and 60 years Opium user according to DSM5 criteria 18 years 60 years Both Having a major comorbid psychiatric illness such as psychosis or bipolar spectrum Having major physical illnesses such as cardiovascular disease - Uncontrolled blood pressure - Uncontrolled diabetes - Uncontrolled thyroid disease F32 R45.8 F11 Major depressive disorder, single episode Other symptoms and signs involving emotional state Mental and behavioural disorders due to use of opioids Treatment - Drugs Treatment - Drugs Intervention-control group A: Patients in this group receive infusion ketamine as an intervention and oral placebo tablet as control. . Ketamine hydrochloride will receive at a dose of 0.5mg/kg, diluted in 0.9% saline, over a 40-minute period by intravenous pump. In addition, two placebo pills will take sublingually Intervention-control group B: Patients will receive oral buprenorphine as intervention and saline infusion as placebo.In this group, patients take two buprenorphine 8 mg tablets sublingually. In addition, they will receive 0.9% normal saline serum for 40 minutes by intravenous pump Depression. Timepoint: Before the intervention, the day of the intervention, 24 hours after the intervention, one week after the intervention. Method of measurement: Beck Depression Inventory. Anxiety. Timepoint: Before the intervention, the day of the intervention, 24 hours after the intervention, one week after the intervention. Method of measurement: Hamilton Anxiety Questionnaire. Suicide idea. Timepoint: Before the intervention, the day of the intervention, 24 hours after the intervention, one week after the intervention. Method of measurement: Beck suicide questionnaire. Shiraz University of Medical Sciences Approved 2021-09-21 Ethics Committee of Shiraz Medical School Unit 1, Negin building, Alley no. 17, Shahid fallahi st., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)