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Evaluation and comparison of the effects and complications of escitalopram and citalopram on depression in patients with chronic renal failure undergoing hemodialysis

Protocol summary

Study aim
Evaluation and comparison of the effect and side effects of escitalopram and citalopram on depression in patients with chronic renal failure undergoing hemodialysis
Design
a prospective, double-blind rct.that 50 patients with major depressive disorder and chronic renal failure who were undergoing hemodialysis treatment referred to Yazd University Hospitals
Settings and conduct
a prospective, double-blind randomized clinical trial .In this study, patients with major depressive disorder and chronic renal failure who were undergoing hemodialysis treatment referred to Yazd University Hospitals were studied.In this study, the patient and the researcher were blinded to the results of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients with mdd with a minimum depression score of 13 with Hamilton Test and psychiatrist approval, patients with renal failure who were undergoing hemodialysis treatment for at least 3 months, and exclusion criteria:Systemic medical disease that interferes with medication use or follow-up, liver failure, hepatitis B and C, HIV/AIDS, Psychiatric disorder other than depression, patient being treated with SSRIs , pregnancy or lactation, opiate and psychotropic addiction, any unbearable side effects in Is sick.
Intervention groups
Initially, the HAMD was completed .After initial evaluation and confirmation of inclusion criteria, they were randomly assigned to either escitalopram or citalopram treatment for 6 weeks.patients were evaluated after 6 weeks of treatment and after completion of HAMD.drug side effects was measured using a questionnaire developed by the researcher
Main outcome variables
Comparison and effect of escitalopram and citalopram on depression in patients with chronic renal failure disorder treated with hemodialysis and evaluation of side effects of these two drugs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200304046698N1
Registration date: 2020-04-09, 1399/01/21
Registration timing: retrospective

Last update: 2020-04-09, 1399/01/21
Update count: 0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Mina Ayatollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4449 3816
Email address
mina_6432@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-11-21, 1398/08/30
Trial completion date
2020-01-21, 1398/11/01
Scientific title
Evaluation and comparison of the effects and complications of escitalopram and citalopram on depression in patients with chronic renal failure undergoing hemodialysis
Public title
Effects of escitalopram and Citalopram on Depression in Patients with Chronic Kidney Failure under Hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major depressive disorder with minimum depression score of 13 with Hamilton Test and psychiatrist approval Patients with renal failure who have been undergoing hemodialysis treatment for at least 3 months
Exclusion criteria:
Systemic medical disease (heart disease, diabetes, epilepsy, hypertension, thyroid) that interferes with medication use or follow-up. Liver failure, Hepatitis B and C, HIV / AIDS Existence of psychiatric disorder other than depression Patient being treated with SSRIs (if previously treated after 3 months treatment) Pregnancy or lactation Addiction to all kinds of drugs and psychotropics The occurrence of any unbearable side effects in the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Actual sample size reached: 46
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a prospective, double-blind, randomized clinical trial. Patients according to the table of random numbers were assigned to receive either escitalopram or citalopram for 6 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the design and principal investigator were kept blind to the assigned study groups.As the drugs were selected from a single drug company and in order to double-blind the study, the escitalopram and citalopram tablets were provided by the pharmacist in a completely similar capsules form drug to the patients and distributed to the patients based on the treatment group and with a confidential code.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.SSU.MEDICINE.REC
Street address
No. 50, molasadra, ershad eslami street, yazs Town,
City
yazd
Province
Yazd
Postal code
8916864651
Approval date
2019-01-25, 1397/11/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.115

Health conditions studied

1

Description of health condition studied
Major depressive disorder, chronic renal failure
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders

Primary outcomes

1

Description
Depression score on the Hamilton scale
Timepoint
Assessment of Hamilton depression score at baseline and 6 weeks after intervention
Method of measurement
Hamilton Depression Inventory

Secondary outcomes

1

Description
Drug side effect
Timepoint
At baseline (before intervention) and 6 weeks after drug administration
Method of measurement
Questionnaire designed by the researcher

Intervention groups

1

Description
The intervention group: In this group escitalopram is prescribed .escitalopram dose increased from 5 mg to 10 mg per day. The drugs were selected from Tehran Pharmaceutical Company and in order to double blind study,escitalopram tablets were provided by a pharmacist in capsule form and distributed to patients based on group therapy and confidential code. Patients' follow-up was performed after 6 weeks of treatment and after completing the course of re-treatment, Hamilton test was examined and drug side effects including: dry mouth, nausea, yawning, sweating, agitation, reduction Appetite, constipation, diarrhea, drowsiness, headache and sexual problems, According to the questionnaire was prepared by the researcher was measured.
Category
Treatment - Drugs

2

Description
The control group: In this group citalopram prescribed.The dose of the drug was increased from 10 mg to 20 mg per day.The drugs were selected from the drug company Poursina and in order to double blind study,citalopram tablets were provided by a pharmacist in capsule form and distributed to patients based on group therapy and confidential code.Patients' follow-up was performed after 6 weeks of treatment and after completing the course of re-treatment, Hamilton's test was examined and drug side effects including: dry mouth, nausea, yawning, sweating, agitation, reduction Appetite, constipation, diarrhea, drowsiness, headache and sexual problems, According to the questionnaire was prepared by the researcher was measured.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital of Yazd, Shahid Rahnemoon Hospital
Full name of responsible person
mina ayatollahi
Street address
Yazd- Shahid Ghandi Boulevard- Ibn Sina St.- Shahid Sadoghi Hospital
City
yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
Sadoghi-hospital@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
Yazd- Shahid Ghandi Boulevard- Ibn Sina St.- Shahid Sadoghi Hospital
City
yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
Sadoghi-hospital@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
mina ayatollahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 50, Ershad eslami St., Safaiieh
City
yazd
Province
Yazd
Postal code
8916864651
Phone
+98 35 3824 0667
Email
mina_6432@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
mina ayatolahi
Position
yazd
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 50, Ershad eslami St., Safaiieh
City
yazd
Province
Yazd
Postal code
8916864651
Phone
+98 35 3824 0667
Email
mina_6432@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
mina ayatollahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
psychiatrics
Street address
No.50,safaeie Ave.,ershad eslami street,yazd Town
City
yazd
Province
Yazd
Postal code
۸۹۱۶۸۶۴۶۵۱
Phone
+98 35 3824 0667
Email
mina_6432@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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