Condition 1: Depressive symptoms in hemodialysis patients. Condition 2: Anxiety symptoms in hemodialysis patients. Major depressive disorder, single episode Generalized anxiety disorder
Conditions
Interventions
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 t
Sponsors
Kerman University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Askari
Kerman University of Medical Sciences
Outcome results
None listed