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IRCT20190404043159N3 IRCT 2021-04-02 Esfahan University of Medical Sciences Evaluation of the Effect of Haloperidol, Risperidone, and Quetiapine in the Delirium of Cancer Patients Evaluation and Comparison of the Effect of Haloperidol, Risperidone, and Quetiapine Medications in the Treatment of Delirium in End-stage Cancer Patients 2020-09-22 anticipated 60 Complete https://irct.ir/trial/55235 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Treatment methods are identified as A, B, and C. Individuals are divided into 3 groups by the random block method. In this way, the first 3 qualified people are selected and included in the study. These 3 people are considered as a triple block and are arranged according to the last digit of the national code. We identify all three compounds and decode them after the last prescription of the drugs for the last block, Blinding description: One person randomizes individuals into three groups and then adjusts the daily dose of the drug until a therapeutic response is achieved. The second person, who has no information about the type of drug used, evaluates patients on a daily basis using a questionnaire and provides the results to the doctor who adjusts the dose of the drug based on the patient code. Patients are also unaware of the type of medication they are receiving. 3 Condition 1: Delirium. Condition 2: Malignancy. Intervention 1: First Intervention group: Abidi's haloperidol tablets (1-6 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached. Intervention 2: Second Intervention group: Abidi's Quetiapine tablets (25-400 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached. Intervention 3: Third Intervention group: Abidi's Risperidone tablets (1-6 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results To whom: Academic researchers Conditions: Scientific uses Where to obtain: Isfahan University of Medical Sciences website How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Mohammad Reza Sharbafchi
No. 18, Hezarjerib Street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Reza Sharbafchi
No. 18, Hezarjerib Street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of any Type of End-stage Cancer Informed Consent of the Patient or Family More than 18 Years Old Diagnosis o Delirium Disorder According to DSM-V Criterion 18 years no limit Both Presence of Major Neurocognitive Disorder Contraindication for Consumption of Antipsychotic Medications F05 C80.1 Delirium due to known physiological condition Malignant (primary) neoplasm, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs First Intervention group: Abidi's haloperidol tablets (1-6 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached. Second Intervention group: Abidi's Quetiapine tablets (25-400 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached. Third Intervention group: Abidi's Risperidone tablets (1-6 mg daily) starting with the minimum dose and increasing daily until the delirium symptoms improve or the drug dose is reached. Delirium Score in Intensive Care Delirium Screening Checklist. Timepoint: Before the intervention and daily for up to 7 days after remission. Method of measurement: Intensive Care Delirium Screening Checklist. Esfahan University of Medical Sciences Approved 2020-09-11 Ethics committee of Isfahan University of Medical Sciences No. 18, Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)