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Simvastatin versus Atorvastatin in the treatment of mild to moderate depression in post CABG patients: a double blind randomized clinical trial

Protocol summary

Summary
Patients will be randomized into two 25 participants groups according to Random Permuted Block. One group will receive 20 mg Simvastatin per day for 6 weeks and the other group will receive 20 mg Atorvastatin per day for 6 weeks. All participants will be evaluated by HAM-D questionnaire at weeks 0, 2, 4, and 6. Side effects of the drugs will be checked at weeks 1, 2, 4, and 6. At the end of the study the effects and the side effects of the both drugs will be compared. At the begining of the study, at week 2 and at week 6, liver enzymes (ALT, AST, ALK, and Bilirubin) and lipids (TG, Total Cholestrol, LDL, and HDL) will be checked.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201410271556N68
Registration date: 2014-10-28, 1393/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-10-28, 1393/08/06
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-10-28, 1393/08/06
Expected recruitment end date
2014-12-27, 1393/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Simvastatin versus Atorvastatin in the treatment of mild to moderate depression in post CABG patients: a double blind randomized clinical trial
Public title
Comparison between the effect of Simvastatin and Atorvastatin in controlling post cardiac surgery depression.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients who have undergone coronary bypass surgery. 2. Patients who based on DSM-IV have major depression and based Hamilton rating scale for depression (Ham-D 17 items) their score is => 18. 3. No psychiatric symptoms 4. Not receiving psychotropic drugs 5. Not receiving antidepressants during the last month 6. Do not receiving ECT during the last two months 7. No thyroid problem 8. Age between 15 and 80 years 9. No liver dysfunction 10. No Muscular disorders 11. Not receiving other antilipid drugs 12. No hypersensitivity to statins 13. LDL => 80 14. Liver enzymes not being elevated at the time of recruitment 15. No life threatening disease 16. No neurological disorders 17. Not being pregnant 18. No breast feeding 19. Giving informed consent Exclusion criteria: 1. Existing other disorders rather than depression, including Bipolar disorders, Schizophrenia, and other psychotic disorders 2. History of drug abuse or dependency within the last three months 3. Probability of suicide or its tendency during the last year 4. Women who are going to be pregnant within the next few months 5. Women who use OCP for pregnancy prevention 6. Patients who have received antidepressants during the last month 7. Patients who have received ECT withing the last two months 8. Patients who need un-usual psychiatric treatments 9. Patients with liver dysfunction 10. Muscular disorders 11. Receiving other antilipid drugs 12. Hypersensitivity to statins 13. LDL < 80 14. Elevated liver enzymes at the time of recruitment 15. Life threatening diseases 16. Neurological diseases
Age
From 15 years old to 80 years old
Gender
Both
Phase
2
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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Keshavarz Boulevard, Ghods Strret
City
Tehran
Postal code
Approval date
2012-10-30, 1391/08/09
Ethics committee reference number
19165

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode

Primary outcomes

1

Description
Depression
Timepoint
At the starting time, two weeks after intervention, four weeks after intervention, and six weeks after intervention
Method of measurement
Hamilton Depression Questionnaire

Secondary outcomes

1

Description
Drugs side effects
Timepoint
First week after starting the study, second week after starting the study, fourth week after starting the study, and sixth week after starting the study
Method of measurement
Drug side effects checklist

Intervention groups

1

Description
Second group will receive 20 mg Atorvastatin per day for 6 weeks.
Category
Treatment - Drugs

2

Description
First group will receive 20 mg Simvastatin per day for 6 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr. Seyed Hesameddin Abbasi
Street address
Tehran Heart Center, North Kargar Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran Heart Center
Full name of responsible person
Dr. Seyed Hesameddin Abbasi
Position
PhD student in Epidemiology
Other areas of specialty/work
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9720
Fax
Email
abbasi.hesam@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Faculty of Medicine, Tehran University of Medical Sciences, Poursina Street
City
Tehran
Postal code
Phone
+98 21 6641 8466
Fax
Email
s.akhond@neda.net
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Dr. Seyed Hesameddin Abbasi
Position
PhD student in Epidemiology
Other areas of specialty/work
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9720
Fax
Email
abbasi.hesam@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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