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Comparison between the effect of Simvastatin and Atorvastatin in controlling post cardiac surgery depression.

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201410271556N68
Enrollment
50
Registered
2014-10-28
Start date
2014-10-28
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression. Moderate depressive episode

Interventions

Intervention 1: Second group will receive 20 mg Atorvastatin per day for 6 weeks. Intervention 2: First group will receive 20 mg Simvastatin per day for 6 weeks.
Treatment - Drugs
Second group will receive 20 mg Atorvastatin per day for 6 weeks.
First group will receive 20 mg Simvastatin per day for 6 weeks.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Hesameddin Abbasi

Tehran Heart Center

abbasi.hesam@gmail.com+98 21 8802 9720

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 17, 2026