Efficacy of Saffron versus citalopram in the treatment of major depressive disorder, with anxious distress: A double blind randomized controlled trial.
The purpose of the present investigation is to assess the efficacy of saffron versus citalopram in the treatment of major depression, with anxious distress in a six-week double-blind controlled trial. Fifty adult outpatients who meet the DSM- 5 criteria for mild major depression, with anxious distress will participate in the trial. Patients who have a baseline Hamilton Rating Scale for Depression score below 20 will be randomly allocated into two groups. Twenty five will receive citalopram 40 mg/day and 25 will receive saffron 30 mg/day. Patients were assessed by a psychiatrist at baseline and after 2, 4 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 and Hamilton Rating Scale for anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501041556N71
Registration date:2015-01-06, 1393/10/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-06, 1393/10/16
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
2015-01-21, 1393/11/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Saffron versus citalopram in the treatment of major depressive disorder, with anxious distress: A double blind randomized controlled trial.
Public title
Efficacy of Saffron in the treatment of major depressive disorder, with anxious distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Presence of Major Depressive Disorder, with anxious distress based on DSM-5 criteria; 2- age between 18 to 65 years old; 3-score lower than 20 in Hamilton Rating Scale for depression.
Exclusion criteria: 1-Psychotic symptoms; 2-receiving another psychotropic medications; 3-receiving any antidepressants during past one month or ECT during past two months; 4-Presence of hypothyroidism; 5-nursing and pregnant women; 6-srious suicidality during the last year; 7-women who want to be pregnant during the future months; 8-women who are receiving OCP; 9-receiveng aspirin and anticoagulants and NSAIDs.
Age
From 18 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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2014-12-22, 1393/10/01
Ethics committee reference number
27225-30-03-93
Health conditions studied
1
Description of health condition studied
Major Depressive episode
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Severity of anxiety
Timepoint
Baseline and weeks: 2, 4 and 6 after beginig of treatment
Method of measurement
By Hamiltion Anxiety Rating Scale
2
Description
Severity of depression
Timepoint
Baseline and weeks: 2, 4 and 6 after beginig of treatment
Method of measurement
By HamiltionDepression Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Cap citalopram 40 mg/day as control group for 6 weeks
Category
Treatment - Drugs
2
Description
Capsule saffron 30mg/day 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 Hospital
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
Tehran University of Medical Sciences, 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
Roozbeh Hospital, South Kargar Street
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
Roozbeh Hospital, South Kargar Street
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
Roozbeh Hospital, South Kargar Street
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)