The purpose of the present investigation is to assess the efficacy of saffron versus fluoxetine in the treatment of major depression, with peripartum onset in a six-week double-blind controlled trial. Fifty adult outpatients who meet the DSM- 5 criteria for mild to moderate major depression, with peripartum onset will participate in the trial. Patients who have a baseline Hamilton Rating Scale for Depression score below 18 will be randomly allocated into two groups. Twenty five will receive fluoxetine 20 to 40 mg/day and 25 will receive saffron 30 mg/day. Patients were assessed by a psychiatrist at baseline and after 1, 3 and 6 weeks after the medication started. Efficacy will be defined as the change from baseline to endpoint in score on Hamilton Rating Scale for Depression .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509201556N82
Registration date:2015-09-21, 1394/06/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-21, 1394/06/30
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
2015-09-25, 1394/07/03
Expected recruitment end date
2015-11-25, 1394/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of saffron and fluoexetine in the treatment of mild to moderate post partum depression :A duble –blind clinical trial
Public title
Saffron in the treatment of post-partum depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of Major Depressive Disorder; with peripartum onset based on DSM-5 criteria; age between 18 to 45 years old; score lower than 18 in Hamilton Rating Scale for depression. Exclusion criteria: -Psychotic symptoms or any other major psychiatric disorder; receiving any antidepressants during past one month or ECT during past two months; Presence of hypothyroidism or hyperthyrodism; srious suicidality or infanticide ideas; substance abuse or dependence uring the last three months
Age
From 18 years old to 45 years old
Gender
Female
Phase
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
23220
Health conditions studied
1
Description of health condition studied
Post partum depression
ICD-10 code
F53
ICD-10 code description
Mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 2-4-6 after beginig of treatment
Method of measurement
by Hamiltion Depression Rating Scale 17-Item
Secondary outcomes
empty
Intervention groups
1
Description
Capsule fluoxetine 20 to 40mg/day as icontrol group for 6 weeks
Category
Treatment - Drugs
2
Description
Capsule saffron 15mg BID as intervention group for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
South Kregar street, Roozbeh
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Keshvarz Blvd
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
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
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
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar Street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
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
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar Street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)