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IRCT20120215009014N204 IRCT 2018-02-03 Hamedan University of Medical Sciences Effect of Sertraline versus Saffron capsule (SaffroMood) on the treatment of major depressive disorder in elderly Effect of Sertraline versus Saffron capsule (SaffroMood) on the treatment of major depressive disorder in elderly: a double blind randomized clinical trial 2018-01-20 anticipated 50 Complete https://irct.ir/trial/29111 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization, 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. 2 Major depressive disorder. Intervention 1: Intervention group: Saffron capsule (SaffroMood) 30 mg daily for 6 weeks. Intervention 2: Control group: Sertraline tablet 50 to 100 mg daily for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of study as well as approval of the financial supporting organization.
public Dr Fatemeh Ramazan Shams
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3827 4184 frsshams@yahoo.com Hamedan University of Medical Sciences scientific Dr Ali Ghaleiha
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3827 4184 alighaleiha@yahoo.co.uk Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 60 to 90 years Major depressive disorder 60 years 90 years Both 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 F33 Major depressive disorder, recurrent Treatment - Drugs Treatment - Drugs Intervention group: Saffron capsule (SaffroMood) 30 mg daily for 6 weeks Control group: Sertraline tablet 50 to 100 mg daily for 6 weeks. Assessing the signs and symptoms of major depressive disorder. Timepoint: Before and 6 weeks after treatment. Method of measurement: Using Hamilton questionnaire. Hamedan University of Medical Sciences Approved 2018-01-13 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)