evaluation of SSRI drugs such as Escitalopram and Sertralin on patints with chronic hemodialysis because of less side effects
Design
Group 1: patients undergo treatment with Escitalopram
Group 2: patients undergo treatment with Sertralin
number of patients in each group are 66 patients
parallel groups
one sided blindness
randomized
phase 4
Settings and conduct
Site of study : Imam Hossein hospital
Study on two groups with chronic hemodialysis according to Beck questionnaire (score above 8)
Group 1 undergo treatment with Escitalopram and Group 2 undergo Treatment with Sertralin
Comparrision of data after 3 months
blindness with person who evaluate results and analyses datas
Participants/Inclusion and exclusion criteria
Depression in chronic hemodialysis patients
Consent for study participation
Age above 21
another psychologic problems in patients
no drug compliance because of drug side effects
data defects
patients undergo another treatments
patients with no follow up
Intervention groups
patients undergo treatment with Escitalopram
patients undergo treatment with Sertralin
Main outcome variables
Effectiveness of drugs basis of beck questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210424051066N1
Registration date:2021-05-23, 1400/03/02
Registration timing:registered_while_recruiting
Last update:2021-05-23, 1400/03/02
Update count:0
Registration date
2021-05-23, 1400/03/02
Registrant information
Name
Mahdieh Miri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2614 5216
Email address
dr.miri2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of sertraline, escitalopram in treatment of depression in patients undergoing chronic hemodialysis
Public title
efficacy of sertraline, escitalopram in treatment of depression in patients undergoing chronic hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Depression in chronic hemodialysis patients
consent for study participation
Age above 21
Exclusion criteria:
another psychologic problems in patients
no drug compliance because of drug side effects
data defects
patients undergo another treatments
patients with no follow up
Age
From 21 years old
Gender
Both
Phase
4
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Person who analyses data
Person who evaluate results
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran.shahid chamran highway,Yaman Street,Shahid Aarabi Street,Beside Taleqani Street
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2021-01-05, 1399/10/16
Ethics committee reference number
26501
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
A01.02
ICD-10 code description
F32
Primary outcomes
1
Description
Effect of SSRI drugs on Depression
Timepoint
one month- two months- three months
Method of measurement
Beck questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Escitalopram group, 1week under treatment with Escitalopream 10 mg and then increase doses of drug in 3 months to maximum dose of 20mg. Monitorig of patients one,two and three months after Escitalopram administration with Beck questionnaire.
Category
Treatment - Drugs
2
Description
Intervention group: Sertralin group,1week under treatment with Sertralin 25 mg and then increase doses of drug in 3 months to maximum dose of 200mg. Monitorig of patients one,two and three months after Sertralin administration with Beck questionnaire.