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

Phase 2

• Conditions: Major Depression.; Major Depressive episode

• Registration Number: IRCT201604261556N90
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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