depression is very common in hemodialysis patients. it has been showed that depression is significantly related to the morbidity and mortality of these patients. In our randomized single blind controlled trial we compare the efficacy of Omega 3 as a known antidepressant agent with Sertraline, another antidepressant drug with known effect on depression in hemodialysis patients We also evaluate the effect of these drugs on general health conditions of theses patients by their effects on Hemoglobin level. In our study a total number of 75 patients will randomized in 3 groups . In Omega 3 group the patients will receive 1500 mg of this drug in 3 divided doses. Sertraline will be given to this group patients in the dose of 50-150 Mg daily. The patients in all groups will receive the medications for 3 months and they will be evaluated at weeks 4,8 and 12 by appropriate clinical amd laboratory tests. The results will be analysed and the data will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201175113N2
Registration date:2012-02-02, 1390/11/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-02-02, 1390/11/13
Registrant information
Name
Seyyed Mohammad Reza Khatami
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2659
Email address
khatamis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
by a grant of Nephrology Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2012-05-03, 1391/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial Comparing the Effect of Omega-3 with Serteraline and Placebo on Depression General Health Conditions Among Dialysis Patients
Public title
Treatment of Depression In Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age more than18 ; patients with depression; patients on hemodialysis
exclusion criteria: use of anti depressant drugs during last 3 months ; participation in related trials in last 3 months ; not cooperative patients ; not signing the consent.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of research deputy of Tehran University of Medical Sciences
Street address
keshavarz blvd., central building of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1473
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5 on dialysis
2
Description of health condition studied
depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
Primary outcomes
1
Description
depression
Timepoint
time 0 and then weeks 4,8,12
Method of measurement
Hospital Depression Rating Scales test and SADS
Secondary outcomes
1
Description
Hemoglobin level
Timepoint
At time 0 and at the end of study
Method of measurement
Laboratory evaluation
Intervention groups
1
Description
group 1(treatmen group) : omega 3 1500 mg daily
Category
Treatment - Drugs
2
Description
group intervention : sertralin 50-150 mg daily
Category
Treatment - Drugs
3
Description
group 3 (control) : placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Seyyed Mohammad Reza Khatami
Street address
Imam Khomeini hospital, Keshavarz blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Reza Khatami
Street address
Imam Khomeini hospital,Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology Research Center, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Reza Khatami
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2659
Fax
Email
khatamis@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rouzbeh Hospital
Full name of responsible person
Seyed Mohammad Araghi
Position
psychiatric assistant
Other areas of specialty/work
Street address
South Karegar Ave.
City
Tehran
Postal code
Phone
+98 912 159 4326
Fax
Email
smdaraghi@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)