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Saffron versus fluoxetine for depression in post-PCI patients

Saffron versus fluoxetine in the treatment of mild to moderate depression in post PCI patients: a double blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201202281556N36
Enrollment
50
Registered
2012-03-01
Start date
2012-03-05
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

Major Depression.

Interventions

Intervention 1: Saffron Capsule maximum 30 mg/day for six weeks. Intervention 2: Fluoxetine Capsule maximum 40 mg/day for six weeks.
Treatment - Drugs
Saffron Capsule maximum 30 mg/day for six weeks
Fluoxetine Capsule maximum 40 mg/day for six weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of Depressive symptoms. Timepoint: Weeks 0, 3 and 6. Method of measurement: Hamilton Depression Rating Scale-17 item.

Secondary

MeasureTime frame
Side effects. Timepoint: Weeks 1, 3 and 6. Method of measurement: Side-effect Checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 6641 8466

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026