Evaluating The effect of fluoxetine on severity of depressive and anxiety symptoms in hemodialysis patients

Phase 4

Recruiting

• Conditions: Condition 1: Depressive symptoms in hemodialysis patients. Condition 2: Anxiety symptoms in hemodialysis patients.; Major depressive disorder, single episode; Generalized anxiety disorder; F41.1

• Registration Number: IRCT20220422054611N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified