Effect of Sertraline versus Saffron capsule (SaffroMood) on the treatment of major depressive disorder in elderly: a double blind randomized clinical trial
To assess the effect of Sertraline versus Saffron capsule (SaffroMood) on the treatment of major depressive disorder in elderly
Design
This is a double-blind randomized clinical trial, phase II, in which 50 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
The eligible elderly with the major depressive disorder who will refer to Sina Hospital during the study period will be enrolled into the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 60 to 90 years
Major depressive disorder
Exclusion criteria:
Thyroid disorder
Psychiatric disorders such as bipolar disorder and schizophrenia
Drug abuse in the past 3 months
Intention to suicide in the past year
Using anti-depression drugs in the past month
Electroconvulsive therapy in the past 2 months
Using anticoagulant or NSAIDS
Intervention groups
Intervention group: Saffron capsule (SaffroMood) 30 mg daily for 6 weeks
Control group: Sertraline tablet 50 to 100 mg daily for 6 weeks.
Main outcome variables
Primary outcome: Assessing the signs and symptoms of major depressive disorder before and 6 weeks after treatment using Hamilton questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N204
Registration date:2018-02-03, 1396/11/14
Registration timing:registered_while_recruiting
Last update:2018-02-03, 1396/11/14
Update count:0
Registration date
2018-02-03, 1396/11/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sertraline versus Saffron capsule (SaffroMood) on the treatment of major depressive disorder in elderly: a double blind randomized clinical trial
Public title
Effect of Sertraline versus Saffron capsule (SaffroMood) on the treatment of major depressive disorder in elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 60 to 90 years
Major depressive disorder
Exclusion criteria:
Thyroid disorder
Psychiatric disorders such as bipolar disorder and schizophrenia
Drug abuse in the past 3 months
Intention to suicide in the past year
Using anti-depression drugs in the past month
Electroconvulsive therapy in the past 2 months
Using anticoagulant or NSAIDS
Age
From 60 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.UMSHA.REC.1396.661
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent
Primary outcomes
1
Description
Assessing the signs and symptoms of major depressive disorder