This randomized double-blind controlled study will be conducted in Tehran Heart Center, Tehran, Iran. Fifty post-PCI patients with a diagnosis of major depressive disorder and Hamilton Depression Rating Scale score of 14-22 will be included. Based on a random permuted block method the patients will be divided into two 25-patient groups. One group will receive Saffron Capsule with a maximum dosage of 30 mg daily and the other group will receive Fluoxetine capsule with a maximum dosage of 40 mg daily.The duration of the trial will be 6 weeks, and the patients will be assessed with Hamilton scale at baseline and at week 3 and 6. The patients will be evaluated with side-effect checklist at week 1, 3, and 6. Using t-test and repeated measure ANOVA the two groups will be compared regarding primary and secondary outcomes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202281556N36
Registration date:2012-03-01, 1390/12/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-01, 1390/12/11
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-05, 1390/12/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Saffron versus fluoxetine in the treatment of mild to moderate depression in post PCI patients: a double blind randomized clinical trial
Public title
Saffron versus fluoxetine for depression in post-PCI patients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
16074
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F32
ICD-10 code description
Primary outcomes
1
Description
Severity of Depressive symptoms
Timepoint
Weeks 0, 3 and 6
Method of measurement
Hamilton Depression Rating Scale-17 item
Secondary outcomes
1
Description
Side effects
Timepoint
Weeks 1, 3 and 6
Method of measurement
Side-effect Checklist
Intervention groups
1
Description
Saffron Capsule maximum 30 mg/day for six weeks
Category
Treatment - Drugs
2
Description
Fluoxetine Capsule maximum 40 mg/day for six weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Shahin Akhondzadeh
Street address
North Karegar Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical neuropsychopharmacology
Other areas of specialty/work
Street address
Roozbeh hospital
City
Tehran
Postal code
Phone
+98 21 6641 8466
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of Clinical Neuropsychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 6641 8466
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical neuropsychopharmacology
Other areas of specialty/work
Street address
Roozbeh hospital
City
Tehran
Postal code
Phone
00
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)