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IRCT20180404039187N9 IRCT 2021-12-18 Tabriz University of Medical Sciences Evaluation effect of Empagliflozin in psychiatric disorders The study of efficacy of Empagliflozin on metabolic effects of atypical antipsychotic drugs in patients with psychiatric disorders: a randomized clinical trial 2021-12-06 anticipated 40 Complete https://irct.ir/trial/60446 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5), Blinding description: The participants (patients) and the researcher who have the task of sampling in the study are all blind during the study. At the patient's level, blindness will be done as the patients do not know in which group (control or intervention group) they are in. The researcher on the basis of lable A or B without knowing the nature of A, B and according to the randomized list will give the medicine to pateints or not. 3 psychiatric disorders. Intervention 1: Intervention group: Take atypical antipsychotic drugs such as olanzapine, clozapine and risperidone with ampagliflozin 10 mg daily. Intervention 2: Control group: Atypical antipsychotic medications such as olanzapine, clozapine, and risperidone. 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 I have not decided yet - its release schedule is not yet known
public Dr Elnaz Shaseb
Pharmacy faculty of tabriz Medical University, Golgaste St, Azadi Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 51666414766 +98 41 3334 1449 elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences scientific Dr Elnaz Shaseb
Pharmacy faculty of tabriz Medical University, Golgaste St, Azadi Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3334 1449 elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Aged 18 - 65 years old Diagnosis of mental disorders with psychosis and psychotic disorders based on DSM-V-TR Stable treatment with atypical antipsychotics (olanzapine, clozapine and risperidone) in the last 6 months (no dose change in the last 30 days) Stable body weight (definition: less than 5% weight change in the last three months before the trial) Body mass index greater than or equal to 25 (BMI≥25) 18 years 65 years Both Pregnancy and lactation A recent history of drug abuse or dependence Hepatic failure (increase in liver trans aminases to 2 times normal) Renal insufficiency (GFR less than 30) Having type 1 or 2 diabetes Dysfunction of the pancreas Cardiovascular disease Uncontrollable blood pressure Treatment with corticosteroids or other hormone therapy Use medication to lose weight in the last 3 months Treatment - Drugs Treatment - Drugs Intervention group: Take atypical antipsychotic drugs such as olanzapine, clozapine and risperidone with ampagliflozin 10 mg daily Control group: Atypical antipsychotic medications such as olanzapine, clozapine, and risperidone Blood pressure. Timepoint: The beginning of the study, the fourth week, the eighth week and the end of the study. Method of measurement: using a sphygmomanometer. Body weight. Timepoint: The beginning of the study, the fourth week, the eighth week and the end of the study. Method of measurement: Using digital scale. Waist circumference. Timepoint: The beginning of the study, the fourth week, the eighth week and the end of the study. Method of measurement: Using a plastic meter. LDL-HDL-TG. Timepoint: The beginning and the end of the study. Method of measurement: Laboratory tests (enzymatic). FBS. Timepoint: The beginning and the end of the study. Method of measurement: Laboratory tests (enzymatic). Tabriz University of Medical Sciences Approved 2021-12-06 Ethics Committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)