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IRCT20220422054611N1 IRCT 2022-05-27 Kerman University of Medical Sciences Evaluating The effect of fluoxetine on severity of depressive and anxiety symptoms in hemodialysis patients Evaluating The effect of fluoxetine on severity of depressive and anxiety symptoms in hemodialysis patients: a randomized, double blind, placebo controlled clinical trial 2022-05-22 anticipated 70 Complete https://irct.ir/trial/63160 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study, Blinding description: Randomization is hidden from researchers and participants, physicians, nurses, and data collection assistants until the statistical analysis is completed. 4 Condition 1: Depressive symptoms in hemodialysis patients. Condition 2: Anxiety symptoms in hemodialysis patients. Intervention 1: Intervention group: Intervention group Patients in the intervention group take 10 mg fluoxetine capsules of Abidi company for one week and if the drug is tolerated, 20 mg daily until the end of eight weeks of treatment. Intervention 2: Patients in the control group will receive a daily capsule that is quite similar in color and size to fluoxetine but contains an inert substance such as starch. Yes - There is a plan to make this available What will be shared: All the potential data can be shared after blinding. When: Six months after the results were published To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr Marjan Shamspour m.shamspour@kmu.ac.ir How to obtain: Official letter to the researchers through Email Comments:

public Fatemeh Askari

Shahid Beheshti hospital, Jomhouri Blv

kerman Iran (Islamic Republic of) 7618834115 +98 34 3211 1396 fatemeh.askari295@gmail.com Kerman University of Medical Sciences scientific Marjan Shamspour

Shahid Beheshti hospital, jomhouri blv

kerman Iran (Islamic Republic of) 7618834115 +98 34 3211 1396 m.shamspour@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) People on hemodialysis who have a score greater than or equal to 16 according to the Beck Depression Inventory II (BDI-II) criterion and who have major depression based on a structured clinical interview (based on DSM-V) Age from 18 to 80 years People who have been on hemodialysis for more than three months and undergo regular hemodialysis three times a week No treatment with antidepressant, benzodiazepines, pregabalin or gabapentin in the previous month No treatment with ECT (Electroconvulsive therapy) in the last 2 months Not being treated for psychotherapy during the study Written consent to participate in the study 18 years 80 years Both History of severe allergic reaction to fluoxetine or intolerable drug side effects Hepatitis B and C and liver failure, history of seizures, uncontrolled thyroid disease, neurological diseases, history of gastrointestinal ulcer (PUD) and gastrointestinal bleeding during the last three months Patients treated with psychiatric drugs as well as taking special drugs such as: warfarin, corticosteroids, triptans, tramadol, Nonsteroidal anti-inflammatory drugs Moderate to severe intellectual disability Patients with a history of dementia Hyponatremia Existence of a serious risk factor for QTc prolongation such as congenital prolonged QT syndrome, long QT history, family history of prolonged QT or sudden cardiac death, hypokalemia, hypomagnesemia, recent heart attack, bradycardia, decompensated heart failure, concomitant use of enzyme inhibitors CYP2D6, use of other QTc prolonging drugs such as metoclopramide, antipsychotics, methadone, erythromycin, fluoroquinolones, fluconazole, etc Patients presented with psychotic feature and having a disorder other than depression such as bipolar disorder, schizophrenia or other psychotic disorders, panic disorder (other anxiety disorders are not excluded), personality disorders, obsessive-compulsive disorder History of stimulants and hallucinogens abuse Pregnant women or women who plan to become pregnant in the next few months Breastfeeding Patients in need of electroconvulsive therapy or in need of hospitalization in a psychiatric center (based on the evaluation and opinion of a psychiatrist) There is a possibility of suicide or a serious desire to commit suicide F32 F41.1 Major depressive disorder, single episode Generalized anxiety disorder Treatment - Drugs Placebo Intervention group: Intervention group Patients in the intervention group take 10 mg fluoxetine capsules of Abidi company for one week and if the drug is tolerated, 20 mg daily until the end of eight weeks of treatment Patients in the control group will receive a daily capsule that is quite similar in color and size to fluoxetine but contains an inert substance such as starch. Evaluation of the severity of depression. Timepoint: The assessment of the severity of depression at the beginning of the study and every two weeks for eight weeks. Method of measurement: By the beck depression inventory II questionnaire score and Montgomery-Asberg Depression Rating Scale. Evaluation of the severity of anxiety. Timepoint: The assessment of the severity of anxiety at the beginning of the study and every two weeks for eight weeks. Method of measurement: By the Hospital Anxiety and Depression Scale- Anxiety subscale. Kerman University of Medical Sciences Approved 2022-04-16 Ethics Committee of Kerman University of Medical Sciences University of Medical Sciences, Haft Bagh Alavi Highway, Kerman Kerman Kerman Iran (Islamic Republic of)