Red yeast rice as an adjutant therapy in the treatment of moderate to severe depression disorder

Red yeast rice as an adjutant therapy in the treatment of moderate to severe depression disorder in post percutaneous coronary intervention patients: A double blind, placebo –controlled, randomized trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201604261556N90

Enrollment

Registered

2016-07-24

Start date

2016-08-15

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. Major Depressive episode

Interventions

Intervention 1: sertraline up to 200 mg per day plus red yeast rice1200 mg BID for 8 weeks. Intervention 2: Sertraline up to 200 mg per day plus placebo for 8 weeks.

Treatment - Drugs

Placebo

sertraline up to 200 mg per day plus red yeast rice1200 mg BID for 8 weeks

Sertraline up to 200 mg per day plus placebo for 8 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Patients underwent angioplasty 2. Have depression based on DSM-5 and score of 20 or more on Hamilton Depression Rating Scale 3. Informed consent. Exclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of depression. Timepoint: Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment. Method of measurement: Hamilton Depression Rating Scale-17 item.	—

Secondary

Measure	Time frame
Side effects. Timepoint: Weeks: 1, 2, 4, 6 and 8. Method of measurement: Side-effect Checklist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

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