IRCT20220422054611N1
Recruiting
Phase 4
Evaluating The effect of fluoxetine on severity of depressive and anxiety symptoms in hemodialysis patients: a randomized, double blind, placebo controlled clinical trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Condition 1: Depressive symptoms in hemodialysis patients. Condition 2: Anxiety symptoms in hemodialysis patients.
- Sponsor
- Kerman University of Medical Sciences
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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