Saffron versus fluoxetine for depression in post-PCI patients
Phase 2
- Conditions
- Major Depression.
- Registration Number
- IRCT201202281556N36
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Inclusion: 1. Patients underwent angioplasty 2. Have depression based on DSM-IV-TR and score of 14-22 on Hamilton Depression Rating Scale 3. Informed consent Exclusion : 1.Psychosis 2. Current use of other psychotropic agents 3.Antidepressant in the last month 4.ECT in the previous two months 5- Thyroid problem 6.Lactation and pregnancy 7. Problems in other DSM axes 8.History of substance abuse or dependence during the last three months 9. High risk of suicide 10. Oral contraception use 11. Women of child-bearing if willing to be pregnant 12.Need for unusual psychiatric treatment
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of Depressive symptoms. Timepoint: Weeks 0, 3 and 6. Method of measurement: Hamilton Depression Rating Scale-17 item.
- Secondary Outcome Measures
Name Time Method Side effects. Timepoint: Weeks 1, 3 and 6. Method of measurement: Side-effect Checklist.