The main aim of this study is to evaluate the antiinflammatory effect of Sertraline in haemodialysis patients with depression. Fifty adult patients with depression based on Beck Depression Inventory (BDI) are randomized to receive sertraline (50 to 200 mg orally once daily) (n = 25) or placebo (n = 25) for 3 month duration. Blood sampling are performed at baseline (before starting sertraline) and 6 and 12 weeks after sertraline and placebo treatment. Inflammatory cytokines, albumin, hemoglobin and hs-CRP are measured for all patients. Demographic & Clinical data regarding the cause of renal failure, current medications, the most recent laboratory values (taken within the past 1 month) and extrarenal co-morbidities such as diabetes mellitus, hypertension, atherosclerotic vascular disease, cardiac failure, cardiac valvular diseases, chronic lung diseases, and chronic hepatitis were obtained from the patient’s medical records.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111228171N1
Registration date:2012-02-23, 1390/12/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-02-23, 1390/12/04
Registrant information
Name
Mohammad Taraz
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
taraz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-04-21, 1391/02/02
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Sertraline effect on serum level of IL-6, IL-10, TNF-α, hsCRP, Albumin and Hemoglobin in Haemodialysis patients with depression
Public title
AntiInflammatory effect of Sertraline in haemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Age between 18 to 80 years; 2- start to Haemodialysis of at least 3 months duration; 3- Receiving maintenance haemodialysis, 4 hour three times per week via a low flux polysulphone dialyser using bicarbonate dialysis fluid; 4- presence of depression based on Beck Depression Inventory (BDI). Exclusion criteria : 1- Patients with major acute infections, autoimmune disease, cancer, severe mental illness, cognitive dysfunction; 2- taking immunosuppressive agents like corticoestroieds for at least 1 month; 3- taking antiinflammatory drugs such as NSAIDs 3-Current use of an antidepressant medication; 4-Intolerance of Sertraline adverse effects.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central organization 6th Floor, Tehran University of Medical sciences, Keshavarz Blvd.